Application of the SUNSET CLAUSE provision for veterinary medicinal products
Taking into consideration:
1. The provisions of Law 1316/83, as amended and in force
2. The provisions of Law 96/73, as amended and in force
3. Articles 28a and 29 par 4-5 of Joint Ministerial Decree 282371/16-6-2006 (Government Gazette B 731/2006)
4. Regulation 726/2004 on Community procedures for the authorisation of medicinal products
We issue the following Circular:
Regarding the regulation of issues concerning the application of the provision on the revocation of a product marketing authorization (Sunset Clause) pursuant to Joint Ministerial Decision 282371/16-06-2006, Government Gazette B 731/2006, it is recalled that:
a) Any marketing authorization for a medicinal product that is not followed by actual marketing within three years of its granting, ceases to be valid and is revoked ipso jure, by a declaratory act of the EOF.
b) Any marketing authorization for a drug that was circulating on the Greek market and whose distribution has been suspended for three consecutive years, ceases to be valid and is revoked ipso jure, by a declaratory act of the EOF.
Actual distribution means the sale within three years of at least one package of any form or content of a product on the Greek Market.
The starting date of application of article 29 of Joint Ministerial Decree 282371/16-06-2006 is June 16, 2006, for products for which a marketing authorization was granted before June 16, 2006.
For products granted a marketing authorization after June 16, 2006, the three-year period is calculated from the date of issue of the product's marketing authorization.
Notification – Justification for exemption:
It is recalled that all Marketing Authorization Holders (MAHs) are required to notify the Hellenic Medicines Authority (EOF) of the date of actual placing of each medicine on the market as well as any discontinuation of the marketing of a product.
MAHs whose products have not been released in any packaging of any form or strength since June 16, 2006 and for three consecutive years, are required to submit a notification to the EOF, by June 16 2009.
The notification will be made in accordance with the attached template which is available and hereThe model should include all approved packaging of each product that has not been in circulation for three years.
The deposit will be made in the protocol with the subject SUNSET CLAUSE and electronically to the address vetsunset@eof.gr.
The MAH, if requesting an exemption from the regulation for a specific product, must include in the notification letter a justification for the non-marketing of the product.
Subsequently, the EOF will check and evaluate the submitted data and the justification for exemption from the regulation on a case-by-case basis. It will then proceed to revoke the marketing authorizations with proven notification to each interested party. This process will be repeated annually on June 16th and will concern products whose three-year non-marketing period expires in the interim.
Exceptions:
Based on paragraph 6 of article 29 of Joint Ministerial Decree 282371/16-06-2006, Government Gazette B 731/2006, for reasons of public health protection, EOF provides exemptions from paragraphs 4 & 5 of the said article. Specifically:
1. For products that are considered unique and irreplaceable and there is no alternative treatment
2 For products for which a marketing authorization has been issued by the Hellenic Pharmaceutical Authority but the provisions of article 70 of Joint Ministerial Decision 282371/16-06-2006, Government Gazette B 731/2006, which concerns the implementation of national disease eradication programs, apply.
3. For products for which Greece is the Reference Country (RMS) in order to avoid creating problems in the other interested Member States (CMS).
4. For products with national marketing authorisations which are necessary for their export to third countries. These authorisations will not be revoked after three years from their issuance. Therefore, exports of products to third countries are considered as marketing.
For all exceptions, filing a notification every three years is considered necessary.
Other exceptions to the application of Article 29 will be considered on a case-by-case basis. (e.g. products used in emergencies to address bioterrorism situations).
Clarifications:
1. In the event of a change of Marketing Authorization Holder (MAH), the new MAH is required to submit a notification according to the template and the necessary justification for evaluation by the EOF.
2. Marketing of a product approved through a Mutual Recognition or Decentralized Procedure only in another interested Member State does not cover the Greek license if no packaging of the product is marketed in the country.
3. The implementation of the sunset clause for centrally approved products is carried out by the EMEA.
The President of EOF
Vassilis Kontozamanis
