Q&A: Other

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Once a veterinary product has received approval from the Commission (the “Commission Decision”) all further procedures connected with the product will fall under “Post-Authorisation Procedures”.

This guidance provides an overview for a number of procedures that occur frequently and addresses a number of questions which Marketing Authorisation Holders (MAHs) may have.

Additional information

 

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1. Which EMA inspection-related activities may occur during the post-authorisation phase?

The Agency’s Inspections Sector activities that may occur during the post-authorisation phase for veterinary related matters include the following: verification of compliance with the principles of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), verification of compliance with pharmacovigilance obligations.

The Sector is responsible for co-ordinating any GMP, GLP, pharmacovigilance inspections requested by the CVMP in connection with the assessment of marketing authorisation applications, post-authorisation applications and/or the assessment of matters referred to the committee in accordance with Community legislation. These inspections may be necessary to verify specific aspects of the manufacture and control of the product and/or to ensure compliance with GMP, GLP, pharmacovigilance obligations and quality assurance systems.

When the MAH anticipates the need for EMA inspections in the context of post-authorisation activities (e.g. addition of manufacturing site,…), it is advised to contact the EMA in advance of submission in order to clarify the requirements and the timeframe applying to such inspections.

MAH is liable to pay a fee for each inspection specifically requested by CVMP in the framework of post-authorisation activities. The basis for charging fees for inspections is provided by Council Regulation (EC) No 297/95, as amended, Article 3(4) refers in broad terms to the fee that may be charged for “any inspection”.

In addition as part of the Agency’s responsibility for the coordination of the supervision of authorised medicinal products under practical conditions of use, the Inspections Sector, in cooperation with the EDQM, operates a Sampling and Testing Programme.

Communication and action by Member States in response to suspected product defects relating to centrally authorised medicines are also coordinated by the Sector.

Apart from inspection and supervision related activities, the Agency has been given responsibility for issuing certificates of medicinal products in accordance with WHO requirements which confirm the status of centrally authorised medicinal products and GMP compliance of the sites manufacturing the pharmaceutical forms.

The Sector also coordinates activities in connection with the GMP annexes of the various Mutual Recognition Agreements (MRA) that have been negotiated between the European Community and non-European countries.

Reference

2. How do I notify EMA of changes to my contact persons specified in the application form?

Applicants/Marketing Authorisation Holders are required to notify the EMA of any upcoming changes to contact persons as specified in the application form in sections 2.4.1 and 2.5.1.1, so that the EMA SIAMED Database can be updated accordingly.

Any of the above changes should be notified exclusively in writing on company headed paper and sent to 
vet.applications@ema.europa.eu.

With regard to the contact person to be stated in section 2.4.4 (QPPV), the notification to the EMA should be handled as follows:

  • If a Detailed Description of Pharmacovigilance System (DDPS – Module 1.8.1) is authorised as part of the Marketing Authorisation (MA), a change in QPPV should be submitted via a Type IAIN variation application, provided that the pharmacovigilance system itself remains unchanged. 
  • In all other cases, the change in QPPV can be simply notified to the EMA as indicated above.

Reference

  • Volume 9B of The Rules governing Medicinal Products in the European Union – Part II - Pharmacovigilance for Veterinary Medicinal Products
3. Could my veterinary medicinal product be subject to parallel distribution? NEW July 2015

Centrally authorised medicinal products placed on the market of one Member State can be marketed in any other part of the European Union (EU) by a distributor ('parallel distributor') independently of the MAH.

The European Commission has given the Agency the responsibility to check compliance of parallelly distributed products with the conditions laid down in EU legislation on medicinal products and with the marketing authorisations. This includes the checking of mock-ups of outer and inner labelling, package leaflets, coloured copies of the repackaged presentations, and wholesale distribution and manufacturing authorisations.

Therefore, prior to initiating parallel distribution of a specific product, parallel distributors must notify the Agency in accordance with the frequently asked questions about parallel distribution.

The Agency will check the conformity of the proposed labelling and package leaflet with the text of the latest annexes to the marketing authorisation for the product concerned within 30 working days following validation of the notification and will notify the parallel distributor of any objections or comments. If there are no objections or when objections have been completely addressed by the parallel distributor, the Agency will issue a notice and send it to the parallel distributor, the national competent authority of the Member State of destination, the national competent authority of the Member State where the parallel distributor is located (if different from the Member State of destination) and the MAH of the medicinal product, informing them that the regulatory check has been completed and indicating that the product proposed for parallel distribution complies with the terms of the marketing authorisation of the centrally authorised medicine concerned.

More details on parallel distribution are available in the frequently asked questions on parallel distribution, which parallel distributors, marketing authorisation holders and national competent authorities may have on the parallel distribution notification procedure.

References

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