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The Medicines (Products for Human Use — Fees) Regulations 1995

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PART IVTYPES OF MARKETING AUTHORIZATION FOR WHICH ONLY ONE PERIODIC FEE IS PAYABLE

1.  Marketing authorizations (parallel import) in respect of which separate marketing authorizations have been granted pursuant to the provisions of Council Directive 65/65/EEC(1) in two or more member States of the European Community, which have no differences having therapeutic effect, from a medicinal product in respect of which a single marketing authorization has previously been granted in the United Kingdom.

2.  Marketing authorizations held in respect of homoeopathic medicinal products or anthroposophic products which are—

(a)two or more attenuations of the same mother tincture or other solution of the same trituration; or

(b)two or more attenuations of a particular combination of mother tinctures, other solutions or triturations.

(1)

OJ No. L22, 9.2.65, p. 369/65. The Directive was amended by Directives 75/319/EEC (OJ No. L147, 9.6.75, p.13); 83/570/EEC (OJ No. L332, 28.11.83, p. 1); 87/21/EEC (OJ No. L15, 17.1.87, p. 36); 89/341/EEC (OJ No. L142, 25.5.89, p.11); 89/343/EEC (OJ No. L142, 25.5.89, p. 16) and 93/39/EEC (OJ No. L214, 24.8.93, p. 22).

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