Frequently asked questions about parallel distribution

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This page lists questions about parallel distribution. The information is available as questions and answers, which the European Medicines Agency (EMA) revises as necessary.

Table of contents


General

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1. Is the Agency parallel-distribution notification procedure mandatory?

Yes, since entry into force of Regulation (EC) No 726/2004 on 20 May 2004, notifications of parallel distribution of centrally authorised medicinal products have become mandatory throughout the Community.

Article 57(o) of Regulation (EC) No 726/2004 of the European Parliament and the Council laying down Community procedures for the supervision of medicinal products and establishing the Agency determines the following task for the Agency:

Checking that the conditions laid down in Community legislation on medicinal products and in the marketing authorisations are observed in the case of parallel distribution of medicinal products authorised in accordance with this Regulation.

In addition, Article 76(4) of Directive 2001/83/EC as amended by Directive 2011/62/EU repeats and reinforces the above legal basis:

In the case of medicinal products which have been granted an authorisation pursuant to Regulation (EC) No 726/2004, the distributor shall submit the notification in accordance with paragraph 3 of this Article to the marketing-authorisation holder and the Agency. A fee shall be payable to the Agency for checking that the conditions laid down in Union legislation on medicinal products and in the marketing authorisations are observed.

Communication COM(2003)839 of the European Commission (EC) clarifies on page 16 that:

Although no further authorisation is required, the Community (in practice the EMA) and national authorities of the Member States in which the medicinal product will be distributed in parallel shall be informed that such parallel distribution will take place in order to enable the EMA to check compliance with the terms of the Community marketing authorisation and the national authorities to monitor the market (batch identification, pharmacovigilance, etc.) and to carry out post-marketing surveillance.

If parallel distributors fail to comply with the above conditions, the national competent authorities may on the basis of Directive 2001/83/EC take regulatory and legal actions against the company, e.g. recall of products, suspension of the wholesale / manufacturing authorisation, suspension of the qualified person, etc.

2. Which mailboxes are to be used for submitting initial notifications, annual updates, notifications of a change or general enquiries?
3. When can a parallel distributor place a product on the market?

A parallel distributor must ensure that a notice letter has been granted by the Agency before placing a product on the market. Until the procedure is finalised and the Agency has issued a notice, it cannot be determined if the proposed repackaged medicinal product complies with the terms of the Community marketing authorisation and the pharmaceutical legislation.

4. Can a centrally authorised product be rebranded?

No, a centrally authorised product cannot be rebranded. The marketing authorisation for centrally authorised products is valid in all Member States of the European Union and the only changes permitted for parallel-distributed products are the changes in the language of the labelling and package leaflet, as specified in European Commission Communication 98/C 229/03:

The only changes to the product which can be required in order to allow parallel distribution are changes in the language of the labelling and package leaflet to comply with Article 4(2) and Article 8 of Directive 92/27/EEC (12)…

5. Can centrally authorised products be sourced from Norway, Iceland and Liechtenstein?

Yes, the principles laid down in section D of European Commission Communication 98/C 229/03 on the Community marketing-authorisation procedures for medicinal products apply. The Agency notification procedures for parallel distribution will also apply for parallel distribution from Iceland, Norway and Liechtenstein, provided the products have been previously harmonised with the Community marketing authorisation. A parallel distributor can therefore source batches of a centrally authorised product in Norway, Iceland and Liechtenstein for parallel distribution in one or more EU Member States.

6. Is it possible to have Switzerland as a Member State of Destination?

Although there is a valid mutual recognition agreement with Switzerland, chapter 15 of this agreement does not cover parallel distribution. A proposal to include a Swiss parallel distributor falls outside the scope of the agreement and cannot be accepted.

7. Is the Agency involved in any trademark issues?

No, the Agency is not involved in any trademark issues and only checks the compliance of the parallel-distributed product with the terms of the Community Marketing Authorisation of the concerned centrally authorised product.

According to Commission Communication 98/C 229/03, the parallel distributor has the obligation to give the trademark owner advanced notice before the repackaged product is put on the market. The trademark owner may demand to be supplied with a specimen of the repackaged product. This was further ascertained by the European Court of Justice with the decision of 26 April 2007 in the case of Boehringer Ingelheim and others vs Swingward Ltd and Dowelhurst Ltd (C-348/04). It was established, that 15 working days seem likely to constitute a reasonable time for this notice, but, the time being purely indicative, it remains open to the parallel distributor to allow a shorter time and to the trademark owner to ask for a longer time to react than that allowed by the parallel distributor.

In accordance withthe European Commission Communication (98/C 229/03) and ECJ case law, it is up to the trademark owner to check if the repacked product does not damage the reputation of the trademark, while the Agency is responsible for checkingthe compliance of the submitted specimens with the terms of the Community Marketing Authorisation.

The Agency does not take decisions or provide guidance on the use of registered trademark symbols. The parallel distributor is allowed to make a reference to the registered trademark in the package leaflet and on the outer labelling (e.g. <Product X> is a registered trademark of <Company Y>) in accordance with trademark legislation.        

A trademark holder can give comments on a repackaged product at any time which should always be acknowledged by the parallel distributor.

8. Can a centrally authorised product be parallel-distributed in a Member State where the marketing-authorisation holder has not yet placed the relevant product presentation on the national market concerned?

When a medicinal product has been authorised at Community level, the marketing authorisation is valid throughout the EU. A parallel distributor may therefore place a particular presentation of a centrally authorised product on the market after obtaining a notice from the Agency even if the MAH has not yet placed this presentation on the market in this Member State.

9. Can a centrally authorised medicinal product continue to be parallel-distributed if suspended or revoked?

No. When a Community Marketing Authorisation of a centrally authorised medicinal product is suspended or revoked, the Marketing Authorisation Holder can no longer distribute the product. The parallel distribution notices for this product will also be suspended or withdrawn.

Once the suspension of the Community Marketing Authorisation is lifted, the suspension of the notices will also be lifted.

If a Marketing Authorisation is voluntarily withdrawn due to commercial reasons, in which case the product remains on the market until the last batch expires and the Agency does not withdraw the notices for parallel distribution.

 

10. What are the responsibilities of a parallel distributor regarding vaccines and blood products?

A parallel distributor is obliged to notify the national Official Medicines Control Laboratory (OMCL) of the Member State of Destination about the parallel distribution of vaccines or blood products.

Additionally, the Agency will send a copy of the notice letter for parallel distribution of a vaccine or blood product to the OMCL of the Member State of Destination.

11. Does the ‘specific mechanism’ apply to parallel distribution?

The specific mechanism applies to parallel distribution. Annex IV (2) of the Act of Accession signed on 16 April 2003 introduced a mandatory notification scheme through the specific mechanism, which is also applicable to Bulgaria and Romania:

With regard to the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia or Slovakia, the holder or beneficiary, of a patent or supplementary protection certificate for a pharmaceutical product filed in a Member State at a time when such protection could not be obtained in one of the above-mentioned new Member States for that product, may rely on the rights granted by that patent or supplementary protection certificate in order to prevent the import and marketing of that product in the Member State or States where the product in question enjoys patent protection or supplementary protection, even if the product was put on the market in that new Member State for the first time by him or with his consent.

Any person intending to import or market a pharmaceutical product covered by the above paragraph in a Member State where the product enjoys a patent or supplementary protection shall demonstrate to the competent authorities in the application regarding that import that one month’s prior notification has been given to the holder or beneficiary of such protection.

Please note that Croatia will be joining the EU on 1 July 2013 and the specific mechanism will be applicable for all products sourced from this country.

The legal responsibility for enforcing intellectual property rights will remain with the patent holder.

When submitting an initial notification or an annual update or notification of a change to the Agency, parallel distributors are required to specify the Member States of Origin and of Destination of the medicinal product they intend to parallel-distribute and to specify whether the specific mechanism applies to the concerned notification. Parallel distributors are also requested to confirm that the patent holder or beneficiary has been given one month’s advance notice in their application when the specific mechanism applies, by attaching a copy of the prior letter to the notification. 

12. Are parallel distributors allowed to open the primary packaging?

No parallel distributors are not allowed to open the primary packaging as this would affect the condition of the product.

European Commission Communication 98/C 229/03 (in section D) outlines:

The original condition of the product inside the packaging must not be directly or indirectly affected and any changes in the size of the package must be duly justified, i.e. it must be demonstrated that they are strictly necessary to market the product distributed in parallel in the Member State of Destination in the same conditions as the product distributed by the marketing-authorisation holder.

This requirement was further specified through the ECJ decision in the case Boehringer Ingelheim et al. vs Swingward Ltd and Dowelhurst Ltd (C-348/04). The ECJ developed conditions, under which the parallel distributor is allowed to alter the original packaging of the medicinal product without the trademark owner being able to object. These conditions are laid down in five criteria (also known as the Bristol-Myers conditions):

Repackaging must be allowed if:

  1. the repackaging is necessary to permit importation (because of national rules or established prescription practices based on standard package sizes)
  2. the repackaging does not adversely affect the original condition of the product
  3. the presentation of the repackaged product is not such as to be liable to damage the reputation of the trademark and of its owner
  4. the new packaging states by whom the product has been repackaged and manufactured
  5. the trademark owner receives prior notice and a specimen of the repackaged product before it is put on sale.

In case of dispute between the trademark owner and a parallel distributor, it is up to the national courts to verify that the original condition of the product inside the packaging is not indirectly affected.

13. Is it possible to source a product from one Member State and parallel-distribute it in the same Member State?

Sourcing a product from one Member State and parallel distributing it in the same Member State is not allowed.

In case more than one Member State of Destination is indicated and in case one or more of these Member States of Destination is are also a Member State of Origin for the other Member States of Destination, please add the following sentence on the notification form: ‘Products sourced from Member State X will not be parallel distributed in Member State X’.

Initial notification

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1. How to apply for a notice for parallel distribution?

Initial notification

Step 1  Request a Eudralink account in order to be able to send an initial notification via a secure platform (see section ‘initial notification’ question 3).

Step 2 Compile documentation including the documents below:

  • A scan of the latest manufacturing authorisation of the parallel distributor or repackager or a reference to EudraGMDP;
  • A scan of the latest wholesale distribution authorisation of the parallel distributor or a reference to EudraGMDP;
  • A scan of the signed cover letter clearly indicating the name of the medicinal product, the strength, the pharmaceutical form, EU number and the pack size and any other relevant information;
  • A completed electronic version of the initial notification form (notification of parallel distribution of a centrally authorised medicinal product) from the official contact person – signature is not required;
  • An editable format of the package leaflet (.doc, .pdf) in the language of the Member State of Destination in accordance with the latest version of the Community marketing authorisation;
  • A colour scan of all sides of the relabelled and repacked outer labelling, as well as the relabelled inner labelling, as they will be marketed in the Member State of Destination, clearly showing the Braille text label if required according to the marketing authorisation;
  • A prior notice letter in case the specific mechanism is applicable.

Step 3 Send documentation via Eudralink to: pd_esubmission@ema.europa.eu.

It is strongly recommended that new parallel distributors submit only one notification when applying for a notice for parallel distribution for the first time and wait for the outcome of the regulatory check in order to avoid the repetition of errors when submitting subsequent notifications.

Should a parallel distributor submit a package by mistake or discover an error in the submitted package, it should be removed on the same day. On the next working day after submission, the fees will become payable, indicated by the package being picked up.

Step 4 Within 35 working days, the Agency will finalise the regulatory check and issue a notice letter if all supporting documentation is satisfactory. If necessary, the parallel distributor will be contacted by a parallel distribution assessor. Please note that all communication regarding a particular application should be directed at the parallel distribution assessor who requested the follow-up information. In case of general queries regarding parallel distribution, please send an email to paralleldistribution@ema.europa.eu.

2. What is EudraLink and how do I submit a EudraLink package?

EudraLink is a secure file-transfer system used by the European medicines regulatory network to exchange information required by regulation. It has been designed to enable files to be sent securely over the internet via a user-friendly web interface.

EudraLink users can create packages containing one or more files, with a maximum size of 40 Megabytes per file, to be collected by specified recipients. For security purposes, packages are encrypted when in storage and in transit using 128bit Strong Encryption.

EudraLink accounts are supplied on a 'one-per-person' basis and should not be shared between users. Parallel distributors with more than one person involved in the notification process should request individual accounts for each person.

Please note that a separate EudraLink message is required for each initial notification or annual update/notification of a change.

The subject of the EudraLink package should include the following information:

  • “Date in ICH format (i.e. YYYY.MM.DD)” “PD Name”_”Product name”_”Last 3 digits of the EU number(s)”_”Submission type”_”Sequence number”

PD name (a short name is acceptable)

Product name (only one product and strength per EudraLink message)

Please note that it is possible to combine different pack sizes of the same product and strength in one EudraLink message, butseparate messages are required for different strengths of the same product and for different products. For example, the following two pack sizes, e.g.:

  • Stalevo (EU/1/03/260/003) 50 mg / 12.5 mg / 200 mg Film-coated tablet (100 tablets);
  • Stalevo (EU/1/03/260/004) 50 mg / 12.5 mg / 200 mg Film-coated tablet (250 tablets)

2010.07.06 ABCD_Stalevo_003_004_initial_00

An exception to this is the annual update. For more information please see section ‘annual update and notification of a change’. 

The body of the message is free and may contain, for example, information on the different attachments. However, we recommend not including too much information in this section. All relevant information should be included in the coverletter.

The EudraLink message must be addressed to pd_esubmission@ema.europa.eu for all initial notifications and to: pd_esubmission_changes@ema.europa.eu for annual updates or notifications of a change. The validity of the EudraLink message must have the maximum expiry period of 90 days and the option 'the recipient(s) must have a EudraLink account to access the package' must be selected.

A Package Tracking facility allows EudraLink users to monitor when their package has been collected. This  enables parallel distributors to acknowledge receipt of information. Once the package has been collected, the fee becomes payable. 

Any subsequent document regarding an ongoing initial notification, annual update or notification of a change should be submitted via e-mail or EudraLink to the same  parallel distribution assessor handling the notification, unless the parallel distributor has been informed about a change in the responsibility. The subject of the e-mail or EudraLink message should follow the instructions mentioned above (e.g. PD name_Product Name_EU Number_02).

General enquiries on the status of a particular notification can be sent to the parallel distribution assessor handling the notification or, to paralleldistribution@ema.europa.eu.

3. How can I apply for a EudraLink account?

Please complete Eudralink account request form and send it as a Microsoft Word document (.doc) in a new e-mail addressed to eudralink@ema.europa.eu.

Service Desk staff will contact the applicant once the EudraLink account request has been approved. Please note that the first three sections ('personal information', 'work information' and 'motivation') are mandatory, but the last section (information on the European Medicines Agency or Member State contact point (product ream leader) for account request if available) may be left blank if this information is not available.

Notes:

  • EudraLink accounts are only available to users who have access to business e-mail accounts in the medical and pharmaceutical industries. Web-based e-mail accounts such as Yahoo!, Hotmail, Gmail etc. are not acceptable.
  • If you already have a EudraLink account and are changing companies or you no longer require your EudraLink account, please contact Service Desk staff at the Agency so they can keep your details up-to-date or delete your account.
  • The EudraLink request form is a legal document. By requesting a EudraLink account, you are agreeing that all the information you have provided is current and correct.
4. What file formats are acceptable?

All documentation should be submitted using file formats that facilitate the assessment of the file on screen. If the type of file you plan to upload and/or send via e-mail is not included in the list below, please convert the file to an acceptable file type.

  
Dataxls (Microsoft Excel Spreadsheet)
Image

bmp (Bitmap Image)

gif (Graphics Interchange Format)

jpg (Joint Photographic Experts Group)

pdf (Portable Document Format)

tif (Tagged Image File Format)

Text

doc (Microsoft Word Document)

docx (Microsoft Word Open XML Document)

pdf (Portable Document Format)

Compressedzip (Zipped File)

PDF documents submitted as scans should be scanned at resolutions that will ensure the pages are legible both on the computer screen and when printed. Normally, 300 dpi gives good results without compromising file size for text. Parallel distributors should ensure that the quality of the renditions is adequate for regulatory review.

5. How to name each file?

Standardisation of the electronic file names is necessary for easy identification of the content and filing in the Agency’s document system. The proposed naming is the following:

'Date in ICH format (i.e. YYYY.MM.DD)' 'PD name'_'Product name'_'Last 3 digits of the EU number(s)'_'Subject'

It is possible to use short names for PD name, provided that it is not ambiguous or confusing and is agreed with the Agency, For example, 'ABCD' instead of 'ABCD Pharma'.

Possible subjects:

  • 'cover' for cover letters;
  • 'form' for notification forms;
  • 'leaflet' for package leaflets;
  • 'labelling' if all labelling (inner and outer) in the same file;
  • 'outer' if outer labelling only in the file;
  • 'inner' if inner labelling only in the file;
  • 'Braille' for Braille text labels;
  • 'manufacturer' for the manufacturing authorisation of the parallel distributor or the repackager;
  • 'wholesale' for the wholesale distribution authorisation of the parallel distributor;
  • 'prior' for the prior notice letter in the frame work of the specific mechanism.

For example:

2010.07.06 ABCD_Stalevo_003 004_Outer

File names should not exceed 230 characters to avoid technical problems. File names should not contain characters that are known to cause problems. Files themselves must not be password-protected or include security settings that may interfere with the process of handling by the reviewers.

6. Are electronic signatures accepted?

Although electronic signatures are currently accepted in the EU as being legally equivalent to handwritten signatures (Directive 1999/93/EC), the Agency does not currently have a system in place for receiving electronic signatures and therefore requires that the cover letter is signed, scanned and included in the documentation package. The cover letter will be the only document requiring a signature. There is no need to send it by post. Other documents do not require a signature.

7. How many initial notifications can be submitted per medicinal product?

A separate notification must be submitted for each EU number and for each Member State of Destination with a different language in use.

8. How quickly will the initial notifications be handled?

Upon receipt of an initial notification, the Agency will validate it within 5 working days and inform the parallel distributor of the start of the regulatory check. If there is any missing or incorrect information, the parallel distributor will be contacted before validation. A Parallel Distribution Assessor will check the compliance of the package leaflet with the date of the latest Annexes of the Community Marketing Authorisation for the concerned medicinal product at the validation stage.

The parallel distributor should provide a response directly to the assessor who requested it and should clearly indicate the subject of the e-mail as follows:

“Date in ICH format (e.g. YYYY.MM.DD)” “parallel distributor’s name”_”Product Name”_”last 3 digits of the EU number(s)”_”Subject” (see section ‘initial notification’ question 5).

NOTE: In order to ensure that there are no delays in the evaluation process, it is not permitted to introduce any new data or make changes once the notification has been validated. Parallel distributors intending to withdraw their initial notification should bear in mind that the relevant fee for the initial notification shall be payable once the package has been collected, that is the following working day after submission.

The Agency will check the conformity of the proposed labelling and package leaflet with the text of the latest Annexes of the Community Marketing Authorisation within 30 working days after validation of the notification, and will notify the parallel distributor of any objections or comments. The notice letter will only be issued after the positive outcome of the regulatory check.

9. Is a wholesale authorisation or a repackager’s manufacturing authorisation needed in order to allow parallel distribution?

Yes, a wholesale authorisation or a repackager’s manufacturing authorisation is needed in order to allow parallel distribution.

All parties (parallel distributor and repackager) must hold the appropriate authorisations for the activities in which they are engaged, e.g. a wholesale distribution authorisation or manufacturing authorisation. The ECJ has defined activities such as 'removal of blister packs from the original external packaging and their insertion into new external packaging' or 'addition to the packaging of new user instructions or information or the fixing of self-stick labels' as repackaging activities that therefore always require a valid manufacturing authorisation. These repackaging activities can be carried out either by the parallel distributor or another company, provided these companies have a valid manufacturing authorisation. In the case of human medicinal products, a manufacturing authorisation may serve as a wholesale distribution authorisation. This information can be obtained from the relevant national competent authority. All authorisations should be available on the EudraGMDP website.

A copy of an up-to-date and complete original authorisation (with attachments) or a EudraGMDP reference should be submitted only with the first initial parallel-distribution notification. It is also recommended to attach an English official translation of the authorisations to facilitate the review and validation by the Agency when a copy of a paper authorisation is submitted. 

For more information please see EudraGMDP.

10. Where can I find the latest published Annexes or Community marketing authorisation?

The latest version of the Annexes of centrally authorised products on the Agency's website are available under European public assessment reports.

To check the latest version of the Annexes via the European Commission’s community registry please visit: Community register of medicinal products.

Note that there might be a discrepancy between the two websites. This might be due to one of the websites not yet having been updated. In that case you should use the annex with the later publishing date.

Most variations are not followed by an immediate Commission gecision, i.e. not falling under Article 23(1)(a) of the Variation Regulation (Regulation (EC) No 1234/2008). Following these variations, the latest version of the Annexes will be available first on the Agency's website.

In case of post-authorisation procedures followed immediately by a Commission decision (e.g. renewals, line extensions, variations falling under Article 23(2) of the Variation Regulation (i.e. new indications, new contra-indications, etc.)), the latest version of the Annexes will first appear on the European Commission website. The EPAR will be updated following Commission decision.

In case of doubt please double-check with the parallel-distribution team by sending an e-mail to paralleldistribution@ema.europa.eu.

On a monthly basis the Parallel Distribution Team will provide you with a SIAMED extract. SIAMED is the Agency’s internal database for recording all data with regards to Centralised products and provides the most accurate information with regards to the latest version of the Annexes. This list should be used in combination with both above named websites when looking up the latest version of the Annexes.

11. Transfers: is it possible to transfer a notice from one company to another?

No, transferring a notice from one company to another is not permitted.

Exceptions

When the transferee is 

  • the sole owner of the transferor following a merger/acquisition and as a result the latter company disappears
  • the transferee is a branch or sister company or a subsidiary of the transferor

If the above conditions are met, the parallel distributor must provide:

  • a notification of a change to inform the Agency that 'company B' will take over the parallel distribution notices of 'company A'
  • the wholesale distribution authorisation and manufacturing authorisation for 'company B'
  • a legal document that confirms that both companies belong to the same organisation

The above is not applicable if the parallel distribution notice is transferred to another Member State of Destination, as this would require a full evaluation and thus a the submission of a new initial notification.

12. Can a parallel distributor use more than one repackager?

Yes, parallel distributors are allowed to identify more than one re-packager in their initial parallel distribution notification. The EudraGMP reference number must be provided. In the case of a new re-packager who is not listed in the Agency database list of repackagers, please provide a copy of their manufacturing authorisation.

On the proposed outer and inner labelling, the parallel distributor can only state one re-packager (and optionally the address), namely the one who is responsible for that particular batch. Only one colour copy with one re-packager has to be provided as an example.

13. How to proceed if sourcing a product from a country where the language is the same as the language in the Member State of Destination?

If a parallel distributor sources a product from a country where the official language is the same as the language in the Member State of Destination (e.g. Ireland, Malta and UK or Austria and Germany) the parallel distributor is still required to provide complete labelling for the product.The European Court of Justice has defined “repackaging” as including operations such as “removal of blister packs from the original external packaging and their insertion into new external packaging” or “addition to the packaging of new user instructions or information or the fixing of self-stick labels’’. If a parallel distributor is planning to add even a small labelling on the outer carton (e.g. with the name of the parallel distributor), this is still considered ‘repackaging’ and needs to be performed by a company that holds a Manufacturing Authorisation.

In such instances, the notification form or signed cover letter should also clearly state for each country involved, that ‘’Products sourced in Member State A will not be parallel-distributed in Member State A.’’

Labelling

Example: If a parallel distributor sources a product in the United Kingdom with the intention to parallel-distribute it in Ireland, the relabeling activity could be limited to adding the details of the parallel distributor, re-packager, original manufacturer and the ‘blue box’ in case the product information is already in compliance with the latest version of the Annexes. If not, the missing additional information in the language of the Member State of Destination should be added to the outer labelling as well.

Parallel distributors must ensure that only the Member State(s) where the product will be placed on the market are mentioned inside the ‘blue box’.

Package leaflet

For example, if a product is sourced in the United Kingdom and the package leaflet is in compliance with the latest version of the Annexes, there is no need to exchange the package leaflet as mentioning the parallel distributor's details and the repackager in the leaflet are not mandatory.

Regulatory check

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1. Are bundle packs allowed?

A parallel distributor can create a bundle pack only if there is a Community marketing authorisation for such a bundle pack with a particular EU number for that medicinal product, which has to be identical to the one on the market.

In this context, which is very different from the parallel import of nationally authorised medicines, the only changes to the product which can be required in order to allow parallel distribution are changes in the language of the labelling and package leaflet to comply with Art. 54, 59 and 63(1) of Directive 2001/83/EC and/or, more rarely, changes in the size of the package (repackaging).

Please note that in case of a bundle pack, the ‘blue box’ needs to be mentioned on each separate box unless otherwise stated in the Annex.

2. Is reboxing allowed?

Parallel distributors have two options for repackaging the medicinal product: relabelling and reboxing.

According to European Commission Communication COM(2003)839, and further specified by ECJ case law, the creation of new packaging is allowed only 

when it is objectively necessary to enable the parallel distributor to have effective access to the market. The trademark owner can only oppose repackaging which he regards to be unnecessary, unless his opposition would contribute to an artificial partitioning of the European Market. (for further information please refer to section 1.13)

If a parallel distributor submits an annual update/notification or change to add re-boxing as an additional repackaging option, the Agency will ask for clarification regarding the pack size of the sourced product, however it will be the responsibility of the parallel distributor to place the product on the market based on the discussions with the MAH and/or NCA regarding re-boxing.

It should be pointed out that this is merely informative and that the Agency is not involved in trademark issues. The Agency only verifies good readability and compliance of the parallel distributed medicinal products with the Community Marketing Authorization.

3. What is the difference between a mock-up and a colour copy?

A mock-up is a copy of the label or flat artwork design in full colour, providing a replica of both the outer and immediate packaging and labelling text of the medicinal product. It is generally referred to as a paper copy or computer generated version.

A colour copy is a digital scan, a digital photograph or a colour photocopy of the (repackaged) sales presentation of the medicinal product.

The printed package leaflet should be representative (format and content) of the sale presentation.

Please always submit a mock-up or colour copy of the outer and inner packaging and an editable version of the package leaflet together with the notification form. The mock-up, colour copies and the editable package leaflet version have to be clear and easily readable. Without these documents, the notification cannot be validated. Please ensure that the labelling and package leaflet are in compliance with the latest version of the Annexes of the Community marketing authorisation.

4. What to do if the MAH or the manufacturer of a particular centrally authorised product has changed?

If the MAH (or the MAH’s address or name) of a particular centrally authorised product has changed, it is recommended that parallel distributors always use the latest version of the Annex when releasing a product. It may happen that different batches of the same product have different MAH details in the labelling for a certain period of time. Since parallel distributors have to repackage the product in accordance with the latest version of the Annex, the sourced carton might still state the old MAH, their logo or their old address. The parallel distributor is then strongly recommended to cover any references to the old MAH on the original carton in order to avoid confusion of the patient.

In case there are changes in the manufacturer’s details, parallel distributors must always use the latest version of the Annex and mention but indicate the manufacturer responsible for the particular batch release as listed in the sourced package leaflet and on the labelling.

5. What to do if the excipients have changed with new batches?

If the product has been sourced from an old batch and some of the excipients have changed, the parallel distributor needs to use the most recent published annex, but mention the excipients as listed in the previous annex.

6. Is it allowed to have any deviations/differences from the text of the latest Annexes?

The Agency checks if the package leaflet and the labelling (inner and outer) of the parallel distributed product are in  compliance with the terms of the Community marketing authorisation in the language of the Member State of Destination. No deviations or differences are allowed.

The following are additional mandatory requirements for the outer labelling, even if they are not mentioned in the Annexes:

  • manufacturer responsible for batch release (as mentioned in the original package leaflet of the concerned batch (name and optionally the address);
  • the words ‘Parallel Distributor/Parallel Distributed by’ (followed by the name and optionally the address);
  • the words ‘Repackager/Repackaged by’ (followed by the name and optionally the address);
  • braille text (if mentioned in section 16 of the Annex);
  • ‘blue box’ (in accordance with national regulations of the Member State of destination).

Optional terms

  • <Product X> is a trademark of <Company Y>;
  • Internal reference number of the parallel distributor (for further information, please see section ‘regulatory check’ question 8).

The following terms are not allowed to appear on the outer labelling:

  • ‘Procured from within the EU’;
  • ‘Imported by’;
  • more than one manufacturer responsible for batch release;
  • any other text that is not part of the latest version of the Annexes (unless justified).

The following terms are allowed to appear on the inner labelling but are not mandatory:

  • ‘Parallel distributor/Parallel distributed by:’ (followed by the name and optionally the address);
  • ‘Repackager/Repackaged by:’ (followed by the name and optionally the address);
  • <ProductX> is a trademark of <Company Y>;
  • Internal reference number of the parallel distributor (for further information, please see sectopm ‘regulatory check’ question 8 ).

Mandatory terms to appear in the package leaflet:

  • Manufacturer responsible for batch release (same as the one on the outer labelling);
  • Local representatives if they are present in the Annexes

Exceptions 

Minor changes are permitted to be introduced by the parallel distributor in the text of the labelling/package leaflet in the following situations and only with the agreement of an Assessor:

  • When the composition of a medicinal product changes the parallel distributor must ensure that the composition mentioned in the leaflet/labelling of the parallel distributed pack corresponds with the actual composition of the pack. The parallel distributor is allowed to modify the text referring to the composition and use the relevant information from the previous Annex. All other medical information should correspond to the latest version of the Annexes;
  • When the term ‘Sealed pack’ is mentioned in the Annexes. There are two options:
  1. If a parallel distributor opens a sealed pack to relabel the box and to replace the package leaflet in such a way that after relabelling the patient will still receive an integral box with the original seal unbroken, then the sentence ‘Sealed pack. Do not use if box has been opened.’ should be included on the outer labelling;
  2. If a parallel distributor breaks the seal in order to relabel the box and to replace the package leaflet and then seals the box with a clear seal the phrase ‘Sealed pack. Do not use if box has been opened.’ should be removed and replaced with ‘Sealed pack has been opened for the purpose of parallel distribution.
7. Can several languages be combined in one pack?

The Community pharmaceutical legislation mentions in Art. 63(1) of Directive 2001/83/EC that all text shall appear in the official language(s) of the Member States where the product is placed on the market.

The labelling and the package leaflet should be in accordance with the text of the Community Marketing Authorisation for the concerned medicinal product in all official languages.

In the case of multilingual Member States of Destination (i.e: Belgium, Finland, etc.), the parallel distributor must combine all languages of that particular country in the package leaflet and on the labelling.

A parallel distributor can create a multilingual pack provided that all particulars required by the Marketing Authorisation appear in all languages concerned, The outer carton should then contain separate blue boxes for each member state of destination.

8. Are combined package leaflets allowed?

If a combined package leaflet is specified in the Community Marketing Authorization, the parallel distributor must create their package leaflet accordingly. This may not be varied either by separating the package leaflets by strength or by creating a combined package leaflet where none is specified.

9. Is it allowed to add internal codes to the labelling?

The parallel distributor is allowed to add an additional re-pack batch number or an internal code, provided that they are not a part of a core text.necessary. The re-pack batch number can be a different number or it can be a derivative of the original batch number with an added prefix or suffix as per the following example.

10. What are the general requirements for Braille text labelling?

The ‘guideline on the readability of the labelling and package leaflet of medicinal products for human use’ as prepared by the European Commission (2009 D/869) sets out advice on the presentation of the content of the labelling and package leaflet and on the design and layout concepts meant to aid the production of high quality information.

The guideline clearly and unequivocally sets out how the requirements for braille text can be met.

As mentioned in the ‘guidance concerning the braille requirements for labelling and the package leaflet’ from the European Commission, these requirements are applicable to parallel distributors.

Further guidance on braille text can be found on national websites as well as:

When submitting specimens or ‘mock-ups’, parallel distributors are recommended to ensure, that the braille text presentation is submitted in the language of the Member State of destination, in accordance with the Annex.

When the original braille text matches the braille text of the country of destination, the original braille text can be maintained provided that legibility and readability criteria apply.

When the original braille text is incorrect or not compliant with the language of the Member State of destination parallel distributors are strongly recommended to cover the incorrect braille text with a thick transparent label (the agency recommends the “resin-dot” label). The differing original braille can be cause for confusion – an assessment of which will be made by the responsible parallel distribution assessor.

The Agency strongly advises parallel distributors to affix the new braille text on a different part of the outer packaging, and not on top of the original one.

The braille text is not mandatory on the immediate packaging (such as blisters, ampoules and bottles) unless required by the marketing authorisation.

The colour copy should make the braille text visible and readable. New braille text presentations must be submitted along with the indication where the braille text will be affixed on the outer packaging.

If the braille text is added on a separate label, a copy of this label should be added to the colour copy of the labelling or the documents submitted with the notification.

11. What are the special requirements for unit dose blisters?

As a general note, when labelling unit dose perforated/peelable blisters, each segment of a perforated blister must be re-labelled individually following the same approach as that of the MAH.

Please note that parallel distributors are not allowed to create a unit dose presentation from a non- unit dose presentation.

12. Is it allowed to cut blisters?

The cutting of blisters is not recommended by the Agency but may occasionally be permitted on a case-by-case basis, provided that it does not affect the original condition of the product and the proposals from the parallel distributor are in accordance with the conditions of the marketing authorisation.

The parallel distributor should provide a valid justification for cutting blisters and a decision on whether this is acceptable will be made by the Agency. Please also note that some countries may forbid the cutting of blisters. The Agency therefore strongly recommends that you contact the national competent authorities where the product will be distributed.

13. How to re-label sterile and foil pack products?

As the original condition of the product may be altered by the opening of a sealed foil pack, a blister or a tray, when re-labelling the blister, syringe, cartridge or other primary packaging, it is the Agency’s recommendation:

  • not to open the tray to re-label the syringe but instead to re-label the tray with all information required for the syringe and the tray preventing any possible contamination of the syringe or of the medicine itself;
  • not to open the aluminium wrapper/foil as the foil provides protection and is important for the maintenance of the shelf life of these products.
14. How many manufacturers are allowed in the package leaflet and on the outer labelling?

Article 59 (f) (vii) of Directive 2001/83/EC requires that the MAH should always state only one manufacturer responsible for the batch release in the original package leaflet.

When more than one manufacturer is indicated in the original package leaflet, the parallel distributor has to contact the MAH to obtain information on the correct manufacturer responsible for that particular batch. On the rare occasion when the original package leaflet states more than one manufacturer, it is essential to notify the Agency about this mistake and the Agency will liaise with the MAH in order to rectify this.

Please note, that only one manufacturer can be mentioned on the outer label, namely the manufacturer responsible for the release of the concerned batch as mentioned in the original leaflet. The manufacturer on the outer label should always correspond to the one in the package leaflet.

15. What is the recommended font-size of the labelling and the package leaflet?

The "guideline on the readability of the labelling and package leaflet of medicinal products for human use" gives recommendations on the font size of the text for the outer and inner labelling and the patient leaflet to ensure their legibility:

Concerning the package leaflet, the guideline states that ‘The type size should be as large as possible to aid readers. A type size of 9 points, as measured in font 'times new roman', not narrowed, should be considered as a minimum.

With regards to the labelling, the guideline states that ‘The particulars appearing on the label of all medicinal products should be printed in characters of at least 7 points (or of a size where the lower case “x” is at least 1.4 mm in height), ….’.

16. What are the requirements for the ‘blue box’?

The ‘blue box’ is mandatory on the outer labelling of each centrally authorised product as well as each parallel distributed product. The information required to appear inside the ‘blue box’ is specific to each Member State. Each ‘blue box’ should must state the name of the Member State of Destination and the information required by the Member State of Destination as described in the guideline on the packaging information of medicinal products for human use authorised by the Community.

The original ‘blue box’ should be completely covered. In principle, the border of the blue box should be blue.

Please note that for bundle packs, the ‘blue box’ must be present on each separate box.

According to Article 57 of Directive 2001/83/EC, a Member State may ask for additional information to appear on the packaging concerning identification and authenticity of the product, the legal category for supply and the price. In addition, Article 57 of Directive 2001/83/EC states that Member States shall observe the detailed guidance referred to in Article 65 of Directive 2001/83/EC when applying Article 57 with regard to centrally authorised medicinal products, such as the “Guideline on the packaging information of medicinal products for human use authorised by the EU”. It has been prepared by the European Commission in agreement with the Member States and the parties concerned in order to describe how provisions of Directive 2001/83/EC apply, including the provisions in Article 57 of Directive 2001/83/EC.

Post-notice guidance

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1. What is the validity of the notice for parallel distribution?

The notice for parallel distribution of a medicinal product is in principle valid for as long as the EU marketing authorisation of the concerned product is in force. The parallel distributed product must always be in conformity with the latest Annex of the EU marketing authorisation for the product.

In order for parallel distributed products to be in compliance with the latest marketing authorisation, an annual update has to be submitted once a year for all products that are currently on the market or for those that will be placed on the market within the next 12 months. (for further information please refer to section 5).

2. Can the Agency request the national competent authorities to perform an inspection of a parallel distributor?

Where considered necessary, the Agency can warn the national competent authorities of any issues or non-compliance that have been brought to the Agency’s attention which may trigger an inspection, in accordance with Article 111 of Directive 2001/83/EC.
The responsibility for any further action remains within the remit of the national competent authorities of the respective Member State(s).

3. What are the parallel distributors’ responsibilities regarding quality defects?

If a parallel distributor identifies a quality defect of the product when sourcing it, or as a result of subsequent handling in the distribution chain, the parallel distributor is accountable and must report this to the Agency.

  1. A parallel distributor can make changes to the packaging materials of a product only if they hold a manufacturing authorisation issued by the relevant national competent authority. They are bound by the provisions of that authorisation, which include compliance with the principles and guidelines of good manufacturing practice (GMP) that are laid down in Directives 2003/94/EC and 91/412/EEC, for human and veterinary products respectively.

    According to Article 13 of Directive 2003/94/EC, manufacturers are required to have a system for recording and reviewing complaints and for effective recall. A manufacturer is obliged to inform the national competent authority of any defect they have become aware of that might result in a recall or abnormal restriction in supply. This applies equally to parallel distributors, as provided for by Article 80 of Directive 2001/83/EC. The national competent authority will assist the parallel distributor in the recall process and will initiate the rapid alert system accordingly. A parallel distributor should ensure that the marketing authorisation holder is informed of any recall initiated by the parallel distributor.
  2. Parallel distributors must only source products from companies which have a valid wholesale distribution authorisation in the Member State where they are located. . The supplier is consequently obliged to inform the parallel distributor of any recall activities that might involve products supplied to the parallel distributor within the supply chain. Such notifications must be handled within the parallel distributor’s GMP/GDP (good distribution practices) system to confirm whether the affected product was actually received, to trace its utilisation and to initiate recall procedures as necessary, including contacting the local competent authority.

When a parallel distributor encounters a quality defect or has any suspicion about the sourced product, the Agency should be informed immediately.

The procedure for reporting quality defects or product recalls is outlined in product defects and recalls.

4. Who receives the notice for parallel distribution?

The notice for parallel distribution is sent to the parallel distributor, the marketing authorisation holder as well as the national competent authorities in the Member State of destination and in the Member State where the parallel distributor is registered. For a vaccine or blood product the notice will also be sent to the official medicines control laboratory (OCML) in the Member State of destination.

5. Is it required to keep reference and retention samples of each product?

Annex 19 of the good manufacturing practice guideline for medicinal products gives guidance on the taking and holding of reference samples of starting materials, packaging materials or finished products and the retention samples of finished products.

A reference sample is a sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned.

A retention sample is a sample of a fully packaged unit from a batch of the finished product. It is stored for identification purposes (i.e. for identifying presentations, packaging, labelling, package leaflets, batch numbers or expiry dates) should the need arise during the shelf life of the batch concerned.

The qualified person for the re-packager/parallel distributor, as defined in the written agreement between the two parties, should keep a retention sample of each batch of the parallel distributed products.

Where the secondary packaging of the original product has been opened during the repacking process
(e.g. to replace the carton or package leaflet) one full retention sample per repackaging activity containing the product (i.e. a fully packaged unit) should be taken, as there is a risk of product mix-up during the assembly process. It is important to be able to identify quickly who is responsible in the event of a mix-up (i.e. original manufacturer or re-packager), as it would affect the extent of any resulting recall.

The samples from each batch of a finished product should be retained for at least one year after their expiry date. Records of traceability should be maintained and be available and accessible for review by the competent authorities at any time.

6. What are the responsibilities of the parallel distributor regarding pharmacovigilance?

According to Title IX of Directive 2001/83/EC, the responsibility for pharmacovigilance lies with the member states and the MAH. The Agency does not request any information regarding pharmacovigilance or the responsible person for pharmacovigilance from the parallel distributor during the notification procedure.

  • For more information on the Article 57 database, see the legal notice.

Should the parallel distributor receive a notification of an adverse drug reaction from a patient, a doctor or any other source, the parallel distributor should inform this person that the adverse drug reactions should be reported directly to the MAH of the medicinal product. The parallel distributor should do the same immediately.

7. What is a product with special conditions for distribution imposed on the marketing authorisation holder?

A product with special conditions is a product which can only be distributed under specific conditions, such as the requirements for educational materials, patient alert cards or controlled distribution system.

If any specific conditions are mentioned in the Annex of the product, it is the responsibility of the Member States to implement these conditions and restrictions. However, the parallel distributors are also required to liaise with the marketing authorisation holder and the national competent authorities in the Member State of destination to discuss the requirements they may need to meet before distributing the medicinal products and to include the information required as per the Annex (e.g. patient alert card) and/or relevant national legislation.

The marketing authorisation holder and the national competent authorities are mainly responsible for agreeing the details of controlled distribution systems and the details of the operation of surveillance programmes. In case a parallel distributed product has not been first put on the market of the Member State of destination by the marketing authorisation holder, the parallel distributor and the national competent authorities should ensure that there is a controlled distribution system, a surveillance programme as well as an educational programme in place (e.g. physician’s pack, patient alert card, etc.), if appropriate, which achieves the aims of the systems required by the conditions of the marketing authorisation for parallel distributed medicinal products.

Annual updates and notifications of change

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1. What to submit: annual update or a notification of change?

An annual update is an alternative (not a substitution) to the notifications of a change. The purpose of the annual update is to combine all scopes of changes occurring within one year to one pharmaceutical form of a medicinal product with one Member State of destination in one application.

One application per product, pharmaceutical form and Member State of Destination gives rise to one fee.

For example, a company holds notices for all four pharmaceutical forms of ‘product X’:

  • tablets;
  • orodispersible tablets;
  • oral solution;
  • solution for injection.

This parallel distributor has to submit four annual updates for 'product X', one for each pharmaceutical form.

An annual update is a “DO and TELL” procedure. A parallel distributor can implement changes and only inform the Agency about these changes with the next annual update.

An annual update needs to be submitted only for the products that have been distributed in the last 12 months and/or for those products which will be distributed in the next 12 months. All other products can be marked as 'dormant' (not active) for a maximum period of 5 years at the request of the parallel distributor.

Products distributed for 12 months with no changes (no new Annex, no new Member States of origin/destination, no changes of labelling, no new re-packagers etc.) do not require an annual update and will not be subject to a fee; however the completed form should be sent to the Agency informing that no changes have occurred since the last annual update. When no form is sent to the Agency, the product will automatically be marked as dormant.

The Agency recommends using the annual update though the notifications of change procedure (“TELL and DO”) will still remain valid for:

Mandatory changes due to the urgent safety updates: notifications of a change resulting from urgent safety updates can be submitted at any time and will be processed according to the standard procedure. These notifications will not be subject to any fee and will not affect the “birthday date” of the annual update. No other scopes of changes can be added to such notifications.

Optional notification of change: can be used to submit new information for one particular EU presentation. These notifications will incur the same fee as the annual update, but they will not affect the “birthday date” of the annual update. The applicable fee is payable EU presentation.

The timeframe for processing an annual update and a notification of a change is 20 working days. The notice letter will be issued only after the positive outcome of the regulatory check.

2. What is a “dormant” product?

A dormant product (or particular EU presentations of a product) is a product which has not been distributed in the last 12 months and will not be distributed within the next 12 months.

A product can be dormant for a maximum of 5 years and can be “re-activated” at any time with the submission of an annual update. If a product is not re-activated within five years, the notice letters will be automatically withdrawn.

3. What is the “birthday date” of an annual update?

The 'birthday date' of an annual update is the date by when an annual update must be submitted. The first 'birthday date' is counted from the date of the last initial notice issued for a certain pharmaceutical form of a particular product for each Member State of Destination. This means that the annual update has to be submitted within a year of the last granted notice.

For example, a parallel distributor holds the following notice letters for product X tablets issued on 5 March 2006, 27 July 2008, 22 December 2008 and 19 February 2013. The first birthday date is February 2014 and the company is required to submit an annual update before the end of February 2014.

The following birthday dates will remain the same for all subsequent annual updates, e.g. if the first annual update was submitted in February 2013, then the second birthday date will be February 2014.

If an annual update has not been submitted by the birthday date, the product will automatically be marked as dormant.

4. When to submit an annual update?

An annual update should be submitted once a year before its “birthday date” only for those products which have been distributed in the last 12 months and/or for those products which will be distributed in the next 12 months.

One application per product, pharmaceutical form and Member State of Destination gives rise to one fee.

An annual update should not be submitted for dormant products.

After the submission of the annual update no other documentation is required, except for the notifications of a change due to the urgent safety updates. In the meantime the parallel distributor can begin compiling the new scopes of changes for the next annual update.

It is strongly recommended that parallel distributors only submit one notification when applying for a notification of an annual update for the first time and wait for the outcome of the regulatory check in order to avoid the repetition of errors when submitting subsequent notifications.

5. How to submit an annual update?

A notification of an annual update has to be supported with the following documentation:

  • a completed electronic version of the annual update form with all EU presentations grouped according to the scopes of changes;
  • a signed cover letter clearly indicating the name of the medicinal product, the strength, the pharmaceutical form, the pack-size and any other relevant information;
  • colour copies of the outer and inner labelling of only one EU presentation of that particular pharmaceutical form preferably showing the most complicated re-packaging option e.g. re-boxing or re-labelling of a product sourced from a Member States of Origin where non-Latin alphabets are in use.

Exceptions

  • When one pharmaceutical form has different routes of administration (e.g. solution for injection in cartridge, syringe and pen), the package leaflet and labelling of each route of administration is required. It will be considered as one notification and will not affect the fee of the annual update;
  • additional documents relating to the particular scopes of changes (e.g. prior letter; authorisations, mock-ups etc.);
  • a report extracted from text comparison software (if applicable).

The above documentation should be submitted electronically via Eudralink to pd_esubmission_changes@ema.europa.eu.

The subject line of the message should state:

'Date in ICH format (i.e. YYYY.MM.DD)' 'PD name'_'Product name'_ 'Pharmaceutical form'_'Annual update' (see section ‘initial notification’ question 5)

6. Text comparison software report

A text comparison report submitted with an annual update/notification of change will attract a reduced fee when the regulatory check of the package leaflet has to be completed. The report should serve as a proof that the submitted package leaflet is in conformity with the latest Annex.

The Agency does not recommend any particular text verification software. It should be text comparison software that preserves data integrity of the documents (i.e. the software should not change the file formats for the text comparison). The created report should ideally juxtapose the deviations in table form. It should be designed to detect the following deviations between the package leaflet and the text of the Annex:

  • change: Text found in the leaflet which replaces the text in the Annex;
  • deviation: Text found in the leaflet that is not identical to the one in the Annex, e.g. typos, grammatical mistakes etc. Please note, if an error is found in the Annex, the parallel distributor should inform the Agency by mentioning the error in the report;
  • deletion: Text found in the annex that is not in the leaflet;
  • insertion: Text found in the leaflet which is not in the Annex;
  • hyphenation: change due to a software-generated hyphen inserted at the end of the line or due to an addition or removal of a hyphen. The Agency's software interprets a missing hyphen as a deletion;
  • case: upper- and lower-case differences;
  • space: change due to an actual space inserted between characters vs. no space.
  • style changes:
    • bold: changed font style (whether text is bold or not);
    • italic: changed font style (whether text is italic or not);
    • underline: change due to text being underlined or not;
    • size: changed font size. Please follow the readability guidelines (font equivalent to Times New Roman 9 for the package leaflet);
    • sub / super: change between regular, superscripted, or subscripted text.

The submitted report must not contain deviations with the exception of the date of the latest revisio as well as the following:

Acceptable deviations in the report

  • The revision date of the most recently published annex.
  • Deletion: text found in the annex that is not in the leaflet: e.g. more manufacturers in the annex, but fewer in the package leaflet.
  • Insertion: text found in the leaflet that is not in the annex: e.g. parallel distributor and repackager’s details, internal code, trademark symbol or sentence.
  • Deviation: text found in the leafletthat is not identical to the one in the annex, e.g. typographical errors or grammatical mistakes. If the product is sourced from an old batch and some of the excipients have changed, the parallel distributor needs to use the most recently published Annex, but mention the excipients as listed in the previous annex.
  • Size: changed font size. Please follow the readability guidelines. Font size must be equivalent to at least Times New Roman 9 for the package leaflet.

Any other deviations will be considered as mistakes and will invalidate the report which will result in the payment of the full fee.

Fees

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1. What are the administrative fees payable to the Agency in relation to parallel distribution?

Pursuant to Article 8 (3) of Regulation (EC) 297/95 “a fee shall apply for administrative services where the information required in the case of parallel distribution has to be checked.” In case of non-payment the Executive Director may refuse to perform the administrative service and return the notification to the parallel distributor or to suspend the service until the fee has been paid, including the relevant interest, Article 10 (3) of Regulation (EC) 297/95.

2. How does the invoicing system work?

The invoice is issued on the date of submission of the notification and is payable within 30 calendar days. The invoice is sent to the billing address indicated by the parallel distributor and contains clear details of the product(s) involved, the amount of the fee, the bank account to where the fee should be paid and the due date for payment.

An application for parallel distribution can be withdrawn without any charges on the day of the submission. The EMA cannot refund the fee if the Eudralink package is withdrawn after 24 hours following submission. No changes are allowed after the parallel distributor receives the validation letter unless requested by the parallel distribution assessor.

3. Fees for an initial notification

A full fee for the parallel distribution regulatory check is applicable to each EU presentation of a medicinal product per Member State of destination.

If the official language in different Member States of destination is the same (e.g. United Kingdom, Ireland and Malta; Germany and Austria; Greece and Cyprus), only one fee is applicable.

The fee covers the regulatory check and any subsequent safety updates relating to the initial notification triggered and adopted by the Committee for Medicinal Products for Human Use or the Committee for Medicinal Products for Veterinary Use.

For more information, see fees payable to the European Medicines Agency.

4. Fees for an annual update

Each annual update is subject to a fee. This fee covers all EU presentations for one pharmaceutical form of a certain product per Member State of destination or for several Member States of destination having the same official language.

A reduced fee is applicable to each annual update if supported with a report generated through text comparison software which meets the specific conditions listed in section 5.6. The reduced fee only applies, where a regulatory check of the package leaflet is required (i.e. update of the Annex, addition of repackager to leaflet, etc.).

For more information, see fees payable to the European Medicines Agency.

5. Fees for a notification of a change

Each notification of a change is subject to a fee. This fee shall cover one EU presentation of a medicinal product for one Member State of destination having one or more official languages, or for several Member States of destination having the same official language.

A reduced fee is applicable to each notification of a change if supported with a report generated through text comparison software which meets the specific conditions listed in the section 5.6. The reduced fee only applies, where a regulatory check of the package leaflet is required (i.e. update of the Annex, addition of repackager to leaflet, etc.).

The reduced fee is subject to the report submitted by the parallel distributor described in section 5.6. (if applicable) and will be granted at the last stage of the evaluation process. The quality of the reports will be monitored by random checks of the package leaflets with the purpose of confirming their validity.

For more information, see fees payable to the European Medicines Agency.

6. Fee regulations – more information