Regulation 22 Amendment of Schedule 3 to the principal Regulations

In Schedule 3 to the principal Regulations (waiver, reduction or refund of fees)—

(a)

in paragraphs 2(1) and 2(2)—

(i)

after “clinical trial certificate” there shall be inserted in each case “or for a variation to or for a renewal of a product licence”; and

(ii)

for “3(a) or 4” there shall be substituted in each case “3(a), 4, 6 or 10”;

(b)

after paragraph 4 there shall be inserted the following paragraph—

“5

The fee payable in respect of each such application shall be waived where—

(a)

a product licence (parallel import) 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/EEC^f1 in more than one Member State of the European Economic Community; and

(b)

those marketing authorisations are indicated on the product licence (parallel import) as having been validly granted in those Member States; and

(c)

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.”.

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.