The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

has the meaning assigned to it by section 4(6) of the Act;

means a United Kingdom marketing authorization;

means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93;

means a relevant medicinal product prepared or dispensed in accordance with a prescription given by a practitioner;

means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and is to be used in a radiopharmaceutical;

means any preparation to be reconstituted or combined with radionuclides in a final radiopharmaceutical, usually prior to its administration;

means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93 or by the licensing authority under the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 and includes a product licence granted by the licensing authority under Part II of the Act;”

includes a relevant medicinal product within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994 and, where a product licence relates to any substance or article which is not a medicinal product, the substance or article to which the licence relates or is intended to relate;

means the import into the United Kingdom from another Member State of the Community of a medicinal product for human use in respect of which there has been granted a Community marketing authorization or a marketing authorization by another Member State of the Community and which has no difference having therapeutic effect from a medicinal product in respect of which a marketing authorization has previously been granted in the United Kingdom;

means a radionuclide produced for the radio-labelling of another substance prior to its administration, other than a radionuclide which is incorporated in or produced from a generator or is included in a radiopharmaceutical;

includes a marketing authorization within the meaning of the Medicines for Human Use (Marketing Authorizations Etc.) Regulations 1994;

means any relevant medicinal product which when ready for use contains one or more radionuclides included for a medicinal purpose.

means a medicinal product for human use to which Chapters II to V of Council Directive 65/65/EEC apply, and accordingly includes the industrially produced medicinal products mentioned in Article 2.2 of that Directive;

means a relevant medicinal product of a description, or falling within a class, specified in an order under section 51 of the Act which is for the time being in force;

includes restrictions;

has the same meaning as in section 131 of the Act;

has the same meaning as in section 131 of the Act.

means the Medicines Act 1968;

means the European Community;

means the European Agency for the Evaluation of Medicinal Products established by Council Regulation (EEC) No. 2309/93;

means the provisions of— • Council Directive 65/65/EEC;

means the period of twenty-eight days or such extended period as the licensing authority may in any particular case allow.

means a marketing authorization granted by the licensing authority under these Regulations.