OpenLegislation

Paragraph 5

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

In relation to a product licence (parallel import), the fee payable in respect of each such application shall be waived—

(a)

where the licence relates to a medicinal product in respect of which a separate marketing authorisation has been granted pursuant to the provisions of Council Directive 65/65/ EECf1 in more than one Member State of the European Economic Community, those marketing authorisations are indicated on the product licence (parallel import) as having been validly granted in those Member States and the holder of that licence applies for the grant of a separate product licence (parallel import) in respect of each marketing authorisation which has been granted and so indicated; or

(b)

the holder of the licence applies for a variation to the licence solely relating to a change in the number of a marketing authorisation referred to in sub- paragraph (a) above.

Annotations

Footnotes

f1

O.J. No. 22, 9.2. 1965, p.369/65, as amended by Council Directives 75/319/EEC O.J. No.L147, 9.6. 1975, p.13, 83/570/EEC O.J. No.L332, 28.11. 1983, p.1, 87/21/EEC O.J. No. L15, 17.1. 1987, p.36 and 89/341/EEC O.J. No. L142, 25.5.1989, p.11.