Regulation 4 Amendment of Schedule 3 to the principal Regulations

After paragraph 1 of Schedule 3 to the principal Regulations (offences, penalties etc.) there shall be inserted the following paragraph—

“1A

In respect of any product which is a relevant medicinal product, where, following a determination under regulation 3A(4) or (5), the licensing authority serve a notice in respect of that product on any person under regulation 3A(6) requiring him—

(a)

to stop marketing the product from a date specified in the notice unless or until a marketing authorization is granted in respect of that product, if after the date specified—

(i)

he places that product on the market, or

(ii)

in the course of a business carried on by him, he sells, supplies to a member of the public or procures for sale or for supply to a member of the public that product,

without a marketing authorization having been granted in respect of that product, he shall be guilty of an offence;

(b)

not to place the product on the market unless or until a marketing authorization is granted in respect of that product, if he thereafter places the product on the market without a marketing authorization having been granted in respect of that product, he shall be guilty of an offence.”.

In paragraph 6(c) of Schedule 3 to the principal Regulations (offences, penalties etc.—obligations of holders of marketing authorizations), after the words “those Articles” there shall be added the words “or paragraph C.a of Part 2 of the Annex to Council Directive 75/318/EEC”.