Q&A: Application of the so-called 'sunset clause' to centrally authorised veterinary medicinal products

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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. Does a product need to be marketed after the authorisation has been granted (“sunset clause”)? Rev. May 2017

The so-called ‘sunset clause’ is defined in accordance with Regulation (EC) No 726/2004, Article 39(4-6).

In the context of the sunset clause provision, the marketing authorisation of a centralised medicinal product will cease to be valid if:

  • the veterinary medicinal product is not placed on the market within three years of the authorisation being granted or,
  • where a veterinary medicinal product previously placed on the market is no longer actually present on the market for three consecutive years.

The European Commission may grant exemptions on public and/or animal health grounds and in exceptional circumstances if duly justified.

2. What are the legal basis and definitions for the “sunset clause” provision? New May 2017

The first and second paragraph of Article 38(4) of Regulation (EC) No 726/2004 introduces the obligation as of 20 November 2005 for all Marketing Authorisation Holders, after the granting of a Marketing Authorisation (MA) for a centrally authorised veterinary medicinal product for veterinary use:

  • to inform the Agency of the dates of actual placing on the market of the veterinary medicinal product in the Member States, taking into account the various presentations authorised;
  • to notify the Agency if the product ceases to be placed on the market, either temporarily or permanently. Such notification shall, otherwise than in exceptional circumstances, be made no less than 2 months before the interruption in the placing on the market of the product.

The terms ‘actual marketing’ and ‘placing on the market’ as referred to in Article 38(4) of Regulation (EC) No 726/2004 should be defined as when the veterinary medicinal product is‘released into the distribution chain’ i.e. out of the direct control of the marketing authorisation holder.

The ‘cessation of placing on the market’ shall be defined by analogy to the placing on the market, to the ‘cessation of release into the distribution chain’ with the consequence that the concerned product is no longer available for supply. It means that the date of cessation shall be the date of the last release into the distribution chain.

Reference

Regulation (EC) No 726/2004of the European Parliament and of the Council of 31 March 2004 laying down Community Procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L136 of 30.04.2004), Art. 57.1(o).

3. Does it apply to existing products? New May 2017

The sunset provision applies prospectively to all centrally authorised veterinary medicinal products from the date of entry into force of the Regulation, i.e. 20 November 2005.

From this date, marketing authorisation holders of centralised authorised veterinary medicinal products have the obligation to inform the Agency of the actual marketing, as well as the cessation of marketing, of their veterinary medicinal products.

4. What are the principles for the monitoring of the sunset clause provision? New May 2017

The marketing authorisation will remain valid if at least one presentation of the authorised veterinary medicinal product is placed on the market in the Community (in at least one Member State) including Iceland, Norway and Liechtenstein.

The marketing authorisation of a centrally authorised veterinary medicinal product includes the initial marketing authorisation and all variations (e.g. additional presentations) and extensions (e.g. new strength or new pharmaceutical form) authorised for this veterinary medicinal product. This notion has been applied since the beginning of the centralised procedure and is reflected in the way the EU numbers are allocated to a centrally authorised veterinary medicinal product and all its presentations.

As referred to in Articles 39 (4) and 39 (5) of the Regulation, a three-year period without marketing may lead to the application of the sunset clause. This will start counting from two different points as detailed hereafter.

Marketing authorisation not followed by actual marketing

In accordance with Article 39(4) of Regulation (EC) No 726/2004, any marketing authorisation which is not followed by the actual marketing in the Community within 3 years after the granting of the authorisation shall cease to be valid.

However, the start of the three years period should be the date when the veterinary medicinal product can be placed on the market by the marketing authorisation holder; i.e. as of the end of the period of market exclusivity of the reference medicinal product and at the end of other protection rules which must be respected.

Veterinary medicinal product previously marketed no longer actually present on the market

In accordance with Article 39(5) of Regulation (EC) No 726/2004, for any veterinary medicinal product previously placed on the market but no longer actually present on the market for three consecutive years, the marketing authorisation shall cease to be valid.

The term ‘no longer actually present on the market’ shall be understood in the same way as ‘ceased to be placed on the market’. Therefore, the sunset clause period shall start from the last date of release by the marketing authorisation holder into the distribution chain of the veterinary medicinal product.

5. What about exemptions to the sunset clause provision? New May 2017

According to Article 39(6) of Regulation (EC) No 726/2004, the Commission may grant exemptions from the application of the sunset clause on public and/or animal health grounds and in exceptional circumstances.

Exemptions can apply at any time of the marketing authorisation life cycle (e.g. at the time of the authorisation, during the marketing of the product, or during the sunset clause period) depending on the type of exemptions.

The marketing authorisation holder may already be aware at the stage of the marketing authorisation application that an exemption might be applicable, for instance for veterinary medicinal products only to be used in emergency situations, in response to public and/or animal health threats duly recognised by the Community, such as vaccines for epizootics.

Procedure for requesting an exemption

The request for exemption should be made by the marketing authorisation holder to the Commission, with a copy to the Agency, as soon as possible after granting of the marketing authorisation, although the intention to request an exemption can be signalled to the Agency earlier. It will be up to the marketing authorisation holder to justify why an exemption should apply based on public and/or animal health grounds and in exceptional circumstances. Each justification should be notified to the Commission and will be considered by the Commission on a case-by-case basis.

6. What are the procedural aspects for monitoring the sunset clause? New May 2017

Below is detailed the concept of the start and stop of the sunset clause period according to the main stages of the marketing cycle of a veterinary medicinal product. This mechanism of the counting of the period without marketing of the product may need to be revised in the future according to the experience gained. The Agency will monitor the application of the sunset clause provision.

When is the “sunset timer” on?

The “sunset timer” will count the days within a certain period when a product is not placed on the market, e.g. from granting the marketing authorisation until first marketing or during a period of cessation. Different situations lead to the start of the counting of the sunset clause period.

a) Granting of the marketing authorisation

At the time of the granting of the marketing authorisation, the veterinary medicinal product may not be immediately placed on the Community market. As a consequence, the timer will start from the date of notification of the granting of the marketing authorisation by the European Commission.

In the case of market exclusivity and other protection rules, which have to be respected, the sunset timer will start from when the marketing authorisation holder can legally place the veterinary medicinal product on the market. The information about market exclusivity of the reference product is available to the Agency, but the information regarding other protection rules might not be known by the Agency. Marketing authorisation holders are therefore advised to inform the Agency of the expiry date of other protection periods to be respected. This should be notified within 60 days from the date of granting of the marketing authorisation; otherwise the three-year sunset clause period will start counting after expiry of the 10 or 11 years of market exclusivity period of the reference medicinal product.

b) A temporary or permanent cessation of placing on the market the veterinary medicinal product

In accordance with the legal requirements, the marketing authorisation holder is responsible to inform the Agency of product cessation in placing on the market. When there is no longer any presentation of the veterinary medicinal product actually placed on the Community market, a (new) sunset timer will start running from the last date of release into the distribution chain of the veterinary medicinal product.

When is the “sunset timer” off?

Different situations lead to the stop of the counting of the sunset clause period.

a) Initial placing on the Community market

The sunset timer will stop running at the time of the first placing on the market of one presentation in one Member State.

b) At the re-placing on the market after a temporary cessation of the whole veterinary medicinal product

As soon as a veterinary medicinal product is again placed on the Community market after a temporary cessation, the sunset timer will stop running at this date.

c) Exemption

As soon as an exemption is granted by the Commission for a veterinary medicinal product, the sunset timer will be stopped.

7. What happens at the expiry of the sunset clause period? New May 2017

Marketing authorisation holders should be aware of the sunset clause timer of their product(s) and for taking any appropriate actions, should they wish to retain the marketing authorisation.At the time of the expiry of the sunset clause period, the Agency will inform the European Commission and the marketing authorisation holder that the sunset clause provision may take effect according to either Article 39 (4) or Article 39 (5) of Regulation (EC) No 726/2004.

8. What information should be reported to the Agency on the veterinary medicinal product marketing status? New May 2017

Pursuant to Article 38 (4), the actual initial marketing of a veterinary medicinal product shall be reported to the Agency indicating presentation, date and Member State. For a centrally authorised veterinary medicinal product, “presentation” corresponds to “pack-size”.

The marketing authorisation holder shall also notify the Agency of a cessation (temporary / permanent) in marketing of their veterinary medicinal product.

Temporary cessation should be reported especially when it may cause a public or animal health concern, e.g. if no other veterinary medicinal product would then be available in the target species for treatment of a severe disease or for the control of a zoonotic disease. The marketing authorisation holder has to exercise his best judgement to determine when it is appropriate to report such a cessation but can always seek advice from the Agency when required.

Marketing authorisation holders are advised that where cessation is due to efficacy, safety and/or quality related issues for which already particular procedures are established, reporting of such cessation is without prejudice to applying the other specific related procedures (e.g. quality defect, pharmacovigilance issues, etc), as appropriate.

In accordance with Article 38(4), a date is to be reported for actual marketing which shall be defined as Day/Month/Year. By analogy, a cessation in placing on the market should also be defined as an exact date. If marketing authorisation holders experience difficulties in identifying the exact date, the cessation date should still be defined as Day/Month/Year, mentioning the last day of the nearest week or month for the purpose of the sunset clause monitoring.

Until availability of an electronic reporting tool, marketing authorisation holders should inform the Agency of the marketing status of their veterinary medicinal product(s) preferably by using the form linked below.

The Agency will send a reminder to MAHs asking to return the completed “marketing status overview” annually, around the 2nd quarter of each year.

Details of the initial placing of the market as well as any subsequent regular updates of the marketing authorisation status should be sent to vet.applications@ema.europa.eu.

In addition, where the MAH identifies that there may be a public or animal health issue with a cessation, the MAH should also inform vet.applications@ema.europa.eu.

Reference

9. When should the marketing authorisation holder report marketing status changes to the Agency? New May 2017

The so-called “marketing status overview” refers to the marketing situation of a veterinary medicinal product at a defined time point of the product life cycle. Marketing authorisation holders should provide the Agency with a “marketing status overview” of their veterinary medicinal product(s) according to the timelines given hereafter and preferably using the form linked below.

If such equivalent information is already included in the data provided for a Periodic Safety Update Report (PSUR) submitted at the same time (e.g. sales volumes per Member State), the PSUR data may replace the “marketing status overview”.

Regular update

The marketing authorisation holder should notify the Agency of the initial placing on the market of the product within the Community within 30 days or at the latest at the time of submission of the next PSUR (information about the first launch date should be included in PSURs, see Volume 9B).

Any subsequent placing on the market or change in the marketing status should be reported at least annually in response to a reminder from the Agency.

For cessation

Permanent or temporary cessations where the marketing authorisation holder identifies that there may be a public or animal health issue should be notified to the Agency at the latest 2 months in advance of the cessation, unless exceptional circumstances apply. However, the marketing authorisation holder is advised to inform the Agency at the earliest possible opportunity i.e. as soon as the interruption is foreseen. If the MAH was thinking of ceasing to market a product several months beforehand, but did not have an exact date defined, the MAH could give the Agency a provisional date and then subsequently follow it up with more precise information.

For cessations which might trigger public or animal health issues, the MAH should provide detailed information to the Agency to deal with such cessation. This should include e.g. grounds, length of cessation period, Member State(s) concerned, company’s intention to provide information to animal health professionals etc.

MAHs are advised that reporting is without prejudice to other procedures. Where cessation is due to issues for which particular procedures are established, the specific related procedure should be followed in addition (e.g. quality defect, pharmacovigilance issues, etc).

It is recognised that there are some cases where the MAH cannot anticipate the interruption of the placing on the market of the veterinary medicinal product within the required timeframe as reasons for the interruption are outside of his control.Cases should be considered on a case-by-case basis. This includes cases of ‘force majeure’ (e.g. burning down of manufacturing site, natural disaster, major manufacturing difficulties, out of stock of active substanceor any ingredient of the veterinary medicinal product including packaging material, urgent safety and quality concerns…), as well as the cases referred to in Article 45 of the Regulation (EC) No 726/2004.

However, when the 2-month notice period cannot be respected, the MAH shall inform the Agency as soon as the interruption is considered likely or known.

Other cessations in placing on the market of any presentation in any Member State (i.e. where no potential public or animal health concern is identified by the MAH), should be reported at the time of the regular reporting of the marketing status overview.

Reference

10. Does the Agency intend to publish information about marketing status of the veterinary medicinal products? New May 2017

Marketing authorisation holders should be aware that once electronic reporting will be in place, the information on the marketing status of the veterinary medicinal product will be made public by the Agencyas “marketed” / “not marketed” based on the data provided.

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