Amendment of Schedule 7 (insertion of Schedule 33A into the 2012 Regulations)
10.—(1) Schedule 7 is amended as follows.
(2) In paragraph 5 of inserted Schedule 33A to the 2012 Regulations (list of countries with equivalent regulatory standards as to the manufacturing of active substances on exit day), after paragraph (e) insert—
“(ea)Republic of Korea;”.
(3) In paragraph 57 of inserted Schedule 33A to the 2012 Regulations (temporary exemption as to the location of an appropriately qualified person for pharmacovigilance)—
(a)in sub-paragraph (2), after “regulation 182(2)(a)”, insert “(obligation on holder to operate pharmacovigilance system) in respect of a relevant UK marketing authorisation or traditional herbal registration”;
(b)for sub-paragraph (3) substitute—
“(3) In this paragraph—
“relevant UK marketing authorisation or traditional herbal registration” means any UK marketing authorisation or traditional herbal registration granted before, on or after exit day to a holder to whom sub-paragraph (2) applies where—
that authorisation or registration is included in the same pharmacovigilance system as the UK marketing authorisation or traditional herbal registration referred to in sub-paragraph (1), and which is operated by that holder under regulation 182(1); and
that pharmacovigilance system was, immediately before exit day, maintained by an appropriately qualified person responsible for pharmacovigilance to whom sub-paragraph (1)(c) applies;
“the transitional period” means the period of 21 months beginning with exit day.”.
(4) After paragraph 57 of inserted Schedule 33A to the 2012 Regulations, insert—
“Temporary exemptions in relation to the pharmacovigilance system master file
57A.—(1) Where paragraph 57(2) applies to a holder—
(a)regulation 182(2)(b); and
(b)Part 1 of Schedule 12A,
do not, subject to sub-paragraph (2), apply to that holder for the transitional period.
(2) Sub-paragraph (1) only applies to a holder if during the transitional period—
(a)the holder maintains an EU pharmacovigilance system master file, and the pharmacovigilance system described in it is the same as the pharmacovigilance system operated for that holder’s UK marketing authorisation or traditional herbal registration under regulation 182(1);
(b)that EU pharmacovigilance system master file complies with the requirements of Chapter 1 of Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council, and regulation 184(1)(b) and (2) (obligation on holder to audit pharmacovigilance system);
(c)the holder’s appropriately qualified person responsible for pharmacovigilance has permanent access to that EU pharmacovigilance system master file;
(d)the holder’s appropriately qualified person responsible for pharmacovigilance has permanent access to any other information concerning the compliance of the pharmacovigilance system operated under regulation 182(1) with the provisions in Part 11 of these Regulations and Schedule 12A; and
(e)the holder provides the EU pharmacovigilance system master file, and the information specified in paragraph (d), to the licensing authority if the licensing authority requests it, within such time period as the licensing authority specifies.
(3) In this paragraph—
“EU pharmacovigilance system master file” means a pharmacovigilance system master file maintained by a holder in an EEA State under Article 104 of the 2001 Directive; and
“the transitional period” means whichever is the shorter period of—
the period beginning with exit day and ending with the day on which the holder’s appropriately qualified person for pharmacovigilance begins to both reside and operate in the United Kingdom; or
the period of 21 months beginning with exit day.”.