108. For the italic heading “Application of Part”, substitute “Interpretation and application of Part”.
109. Before regulation 125 (traditional herbal medicinal products), insert—
124A. In this Part, “relevant list” means—
(a)the list referred to in Article 16f(1) of the 2001 Directive, as that list may be amended from time to time; or
(b)if the licensing authority publishes a list under regulation 126A(1), that list.”.
110. In regulation 125(5)(b), for “European Union” substitute “United Kingdom or a country included in the list published under regulation 125A(1)”.
111. After regulation 125 insert—
125A.—(1) The licensing authority may publish a list of countries for the purposes of regulation 125(5)(b) (condition D).
(2) In establishing the list under paragraph (1), the licensing authority may only include a country in that list if it is satisfied that—
(a)continuous use evidence in respect of that country can be sufficiently validated by the licensing authority; and
(b)the country has a level of pharmacovigilance that is equivalent to that in the United Kingdom to ensure that any safety issues in respect of the herbal medicinal product have been properly identified.
(3) The licensing authority must—
(a)review any list it publishes under paragraph (1) to determine if a country still satisfies the criteria for inclusion in the list specified in paragraph (2), and if it is not so satisfied, remove that country from the list; and
(b)undertake such a review at least every three years beginning with the date on which the country is included in that list.”.
112. After regulation 126 (addition of vitamins or minerals) insert—
126A.—(1) The licensing authority may establish, and publish a list of, herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
(2) A list established under paragraph (1) must contain, with regard to each herbal substance—
(a)the indication;
(b)the specified strength and posology;
(c)the route of administration; and
(d)any other information necessary for the safe use of the herbal substance as a traditional medicinal product.
(3) The licensing authority may review and amend any list it publishes under paragraph (1) at such intervals as it considers appropriate.”.
113. In regulation 127(3), for “European Union” substitute “United Kingdom”.
114. In regulation 128(3), for “list referred to in Article 16f(1) of the 2001 Directive” substitute “relevant list”.
115.—(1) Schedule 12 is amended as follows.
(2) In paragraphs 16 and 17, for “another member State or a third country” substitute “a country other than the United Kingdom”.
(3) In paragraph 21—
(a)for “Article 23 of Regulation (EC) No 726/2004” substitute “regulation 202A”;
(b)before “statement”, insert “symbol and”; and
(c)before “This”, insert “▼”.
116.—(1) Regulation 130 is amended as follows.
(2) In paragraph (6), insert “UK” before “marketing authorisation”.
(3) In paragraph (7), for “Article” to the end substitute “regulation 130A.”.
(4) In paragraph (8), for “list referred to in Article 16f(1) of the 2001 Directive” substitute “relevant list”.
(5) Omit paragraph (9).
(6) In paragraph (10)(a) for “Article 16h(3) of the 2001 Directive” substitute “regulation 143A”.
(7) Omit paragraphs (12) and (13).
117. After regulation 130 (consideration of application) insert—
130A.—(1) Where an application for a traditional herbal registration has been made and the licensing authority considers that—
(a)the traditional herbal medicinal product does not satisfy regulation 125(5)(b) (Condition D); but
(b)otherwise satisfies the conditions in regulation 125,
the licensing authority may refer the matter to the appropriate committee for relevant advice, and the procedure in Part 3 of Schedule 11 applies (referral to the appropriate committee for traditional herbal registrations).
(2) In this regulation—
“appropriate committee” has the same meaning as in paragraph 2(4) of Schedule 11;
“relevant advice” means advice as to whether—
the conditions in regulation 125, other than condition D, are met in relation to the application; and
the licensing authority should exercise its powers under regulation 143A to establish a herbal monograph.”.
118. In regulation 133(2), for “European Union” substitute “United Kingdom”.
119.—(1) Regulation 135(1) is amended as follows.
(2) In paragraph (7)(b), for “from states other than EEA States” substitute “countries other than approved countries for import”.
(3) Omit paragraph (8).
(4) In paragraph (9), omit sub-paragraph (b) (and the “and” immediately preceding it).
(5) Omit paragraph (11).
120.—(1) Regulation 136 is amended as follows.
(2) In paragraph (1)(a), for “list referred to in article 16f(1) of the 2001 Directive” substitute “relevant list”.
(3) Omit paragraph (3).
121. Omit regulation 138(10).
122. Omit regulation 139.
123. In regulation 140(1)(a), for “regulation 135, 136, 139(2) or Article 34(3) of the 2001 Directive” substitute “regulation 135 or 136”.
124. In regulation 141(1), omit “or 139(2)”.
125. Omit regulation 142(5C)(2).
126. After regulation 143 (obligation to take account of scientific or technical progress) insert—
143A.—(1) The licensing authority may establish herbal monographs for herbal medicinal products and traditional herbal medicinal products.
(2) Subject to paragraph (3), the licensing authority must—
(a)consult the appropriate committee, within the meaning of paragraph 2(4) of Schedule 11, on a proposal to establish herbal monographs under paragraph (1); and
(b)take the advice of the appropriate committee into account in determining whether to proceed with that proposal.
(3) Where an application for a traditional herbal registration has been referred to the appropriate committee by the licensing authority under regulation 130A, the licensing authority must consider whether to exercise its powers under paragraph (1), taking into account any relevant advice of the appropriate committee given under Part 3 of Schedule 11 in relation to that application.
(4) The licensing authority must publish a list of any herbal monographs established under this regulation.
(5) Until the licensing authority exercises the power under paragraph (1), the Community herbal monographs published from time to time under Article 16h(3) of the 2001 Directive continue to apply, and holders of a traditional herbal registration and the licensing authority must continue to take them into account in exercising any function or in relation to any obligation to which they are relevant under this Part.”.
127. In regulation 144, for “Article 16h(3) of the 2001 Directive” substitute “regulation 143A”.
128. In regulation 145(5)(a), for “which is not an EEA State” substitute “other than the United Kingdom”.
129. In regulation 146(2), for “European” to the end substitute “the UK web-portal established in accordance with regulation 203(1).”
130. After regulation 148 (obligation to ensure appropriate and continued supplies) insert—
148A.—(1) Where, in the event of a risk to public health, the holder of a traditional herbal registration takes urgent safety restrictions on its own initiative, it must inform the licensing authority immediately.
(2) If the licensing authority has not raised objections within 24 hours following receipt of that information, the urgent safety restrictions are deemed to be accepted by the licensing authority.
(3) In the event of a risk to public health, the licensing authority may impose urgent safety restrictions.
(4) Where an urgent safety restriction is taken by the holder of a traditional herbal registration, or imposed by the licensing authority, the holder must submit an application for variation of that registration in relation to that restriction within 15 days beginning with the date of the initiation of that restriction.”.
131.—(1) Regulation 149 is amended as follows.
(2) In the heading to regulation 149, at the end insert “: offences”.
(3) In sub-paragraph (a), for “or the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008” substitute “in accordance with regulation 148A(1)”.
(4) In sub-paragraph (b), for “or the European Commission under Article 22(2) of that Regulation” substitute “in accordance with regulation 148A(2)”.
(5) For sub-paragraph (c), substitute—
“(c)fails to submit an application for variation of the traditional herbal registration to the licensing authority in accordance with regulation 148A(4) before the end of the period of 15 days beginning with the day after—
(i)the taking under regulation 148A(1), or
(ii)the imposition under regulation 148A(2),
of an urgent safety restriction.”.
Regulation 135 was amended by S.I. 2013/1855.
Regulation 142 was amended by S.I. 2013/2593.