- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
1. The application for a certificate shall contain:
(a)a request for the grant of a certificate stating in particular:
(i)the name and address of the applicant;
(ii) if he has appointed a representative, the name and address of the representative;
(iii)the number of the basic patent and the title of the invention;
(iv)the number and date of the first authorization to place the product on the market, as referred to in Article 3(b) and, if this authorization is not the first authorization for placing the product on the market in the Community, the number and date of that authorization;
(b)a copy of the authorization to place the product on the market, as referred to in Article 3(b), in which the product is identified, containing in particular the number and date of the authorization and the summary of the product characteristics listed in Article 4a of Directive 65/65/EEC or Article 5a of Directive 81/851/EEC;
(c)if the authorization referred to in (b) is not the first authorization for placing the product on the market as a medicinal product in the Community, information regarding the identity of the product thus authorised and the legal provision under which the authorization procedure took place, together with a copy of the notice publishing the authorization in the appropriate official publication.
2. Member States may provide that a fee is to be payable upon application for a certificate.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include: