Marketing authorisation exemptions from requirement

The schedule only provides exemptions from the requirement to hold a marketing authorisation. Other activities involved in the supply of medicines on a particular patient basis need to be carried out under the appropriate authorisations. 

Section 8(2) of the Medicines Act 1968 requires those involved in the manufacture or assembly of a medicinal product to hold a manufacturer s licence. In fact. Schedule 1 to 1994 Regulations requires the manufacturer/assembler in the United Kingdom of an unlicensed product for particular patient supply to hold a particular type of manufacturer s licence (a manufacturer s special licence). It should also be noted that Section 23 of the act prohibits the manufacture of a medicinal product unless that product has a marketing authorisation, or is exempt from the marketing authorisation requirement. 

The provisions of Article 23(a) require the MAH to inform the competent authority about various activities associated with the availability of the product on the market. Under Article 24 of the revised legislation only a single renewal is required when the product has been authorised for 5 years. A second renewal may take place after a further 5 years if there are justified pharmacovi-gilance groimds. In addition, any authorisation, which is not followed by placing the product on the market within 3 years (or which is not present on the market for 3 years), shall cease to be valid. Member States may grant exemptions from the 3-year rule, if justified on public health grounds. 

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