Paragraph 1 Content of the application for a certificate

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 authorized 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.

Notes on Part 1

Footnotes

f1: OJ No. C114, 8.5.1990, p. 10.
f2: OJ No. C19, 28.1.1991, p. 94 and OJ No. C150, 15.6.1992.
f3: OJ No. C69, 18.3.1991, p. 22.