Law for human medicines CIRCULAR 66361/13-10-2008:
Implementation of SUNSET CLAUSE provision for medicinal products for human use
The Greek National Organization for Medicines having regard to:
a) The provisions of Law 1316/83 as amended and in force
b) The provisions of Law 96/73, as amended and in force
c) Articles 37 and 38 of Ministerial Decree ΔΥΓ 3 (α) 83657/24-01-2006 (Gazette B' 59/2006)
d) Regulation (EC) 726/2004 of the European Parliament laying down Community procedures for the authorisation and supervision of medicinal products
Has adopted the following:
Regarding the implementation of the provision for the revocation of the marketing authorisation of a product (Sunset Clause) the following apply:
a) Any marketing authorisation, which it is not followed by the actual placing of the registered product on the market, within three years since its granting, ceases to be valid and will be rightfully revoked.
b) The marketing authorisation of any product, which has been launched on the Greek market and is no longer marketed for three consecutive years, will cease to be valid and it will be rightfully revoked.
"Actual placing" means the sale of at least one pack of one presentation, of any pharmaceutical form or strength, in the Greek market.
The effective date for the implementation of article 38 (Sunset Clause) of the Common Ministerial Decision 3 () 83657/24-01-2006 is the 24th of January 2006, for those products for which the marketing authorisation was granted before the 24th of January 2006.
For products, with a marketing authorisation granted after the 24th of January 2006, the three years time period starts from the date of granting.
Notification - Justification for exemption:
All Marketing Authorisation Holders (MAHs) are obliged to notify EOF of the date of actual placing of each medicinal product on the market as well as any potential withdrawal from the market.
The MAHs who have not placed on the market any presentation of any pharmaceutical form and strength of a product since January 24th 2006 for three consecutive years, must submit to EOF a notification by January 24th 2009.
The attached notification template document must be filled in accordingly. All registered presentations of a product, which is not on the market for a three years period, must be included in this document.
The document must be submitted both in hard copy at EOF and electronically to the e-mail address sunset@eof.gr.
If the MAH requests an exemption for a specific product, justification must be provided accordingly.
EOF will check and assess the submitted data on a case by case basis. Consecutively, EOF will proceed to the revocation of the marketing authorisation with a confirmed notice to all concerned parties. This procedure will be repeated on an annual basis each January 24th for all products for which the three years non-marketing period expires in the interim time.
Exemptions:
Based on paragraph 6 of article 38 of the Common Ministerial Decision 3 () 83657/24-01-2006 Gazette B' 59/2006, for public health grounds, EOf will not apply the Sunset Clause on public health grounds. Specifically:
1. For products which are deemed as therapeutically necessary and which mainly fall in the following categories:
- Vaccines - sera
- Insulins
- Blood products
- Orphan medicinal products
- Medicinal products for tropical diseases
2. Products for which Greece is Reference Member State (RMS), thus avoiding the creation of problems to the Concerned Member States (CMS)
3. Nationally authorized products for which the relevant marketing authorization is necessary for export. These MAs will not be revoked since exporting to third countries is considered as placement on the market.
For all exemptions it is still mandatory to submit the notification every three years.
Other exemptions from the implementation of article 38 will be examined as separate cases (e.g. products that are used in case of emergency against bioterrorism).
Clarifications:
1. In case of transfer of a Marketing Authorisation Holder (MAH) to another MAH, the new MAH must submit to EOF the notification according to the template and the necessary justification for evaluation.
2. The placing on the market of products registered through MRP or DCP on a member state other than Greece, does not cover the obligations deriving from the Greek MA as it concerns sunset clause.
Vassilis Kontozamanis
President of EOF
