A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application—
(a)
the product is protected by a basic patent in force;
(b)
a valid authorization to place the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as appropriate;
(c)
the product has not already been the subject of a certificate;
(d)
the authorization referred to in (b) is the first authorization to place the product on the market as a medicinal product.
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.