The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

103.  For regulation 135 (amendment of regulation 168 (use of non-prescription medicines in the course of a business)), substitute— U.K.

“Amendment of regulation 168 (use of non-prescription medicines in the course of a business)

135.   In regulation 168 (use of non-prescription medicines in the course of a business), for paragraph (8) substitute—

“(8) Condition G is that if the medicinal product is—

(a) manufactured or assembled in the United Kingdom or imported into the United Kingdom from—

(i) in the case of a product for sale or supply in Northern Ireland, a country other than an EEA State, or

(ii) in the case of a product for sale or supply in Great Britain, a country other than an approved country for import,

it is manufactured, assembled or imported by the holder of a manufacturer's licence that relates specifically to the manufacture, assembly or importation of special medicinal products, or

(b) imported into—

(i) Northern Ireland from an EEA State, it is manufactured or assembled in that State by a person who is the holder of an authorisation in relation to its manufacture or assembly in accordance with the provisions of the 2001 Directive as implemented in that State, or

(ii) Great Britain from an approved country for import—

(aa) it is manufactured or assembled in that country by a person who is the holder of an authorisation in that country in relation to its manufacture or assembly, and

(bb) it is imported by the holder of a wholesale dealer's licence under Part 3 that includes the import of a medicinal product from such a country.”.”.

Commencement Information

I1 Sch. 2 para. 103 in force at 31.12.2020 immediately before IP completion day, see reg. 1