Made | 6th October 2005 | ||
Laid before Parliament | 7th October 2005 | ||
Coming into force | |||
Except for the purposes of paragraphs 4(2)(a) and 8(a)(i) of Schedule 7 | 30th October 2005 | ||
For the purposes of paragraphs 4(2)(a) and 8(a)(i) of Schedule 7 | 20th November 2005 |
Interpretation
2.
—(1) In these Regulations—
that committee; and
(b) in any other case, the Commission;
(2) Expressions used in these Regulations which are also used in the 2001 Directive shall have the same meaning as they have there and related expressions shall be construed accordingly.
(3) Subject to paragraph (2), section 11 of the Interpretation Act 1978[9] shall apply for the interpretation of these Regulations as if they were made in the exercise of a power conferred by the Act.
(4) Any reference in these Regulations to an application that is signed includes a reference to an application that is signed with an electronic signature.
Responsibility for Member States' functions in relation to traditional herbal medicinal products
3.
—(1) In so far as they relate to traditional herbal medicinal products and fall to be performed by, or by any authority of, the United Kingdom, the functions of a Member State, or of the competent authority of a Member State, under any of the relevant Community provisions shall, subject to paragraph (2), be performed by the licensing authority.
(2) Paragraph (1) shall not apply in so far as any such functions fall to be performed by the exercise of any powers or duties which are conferred by any provision of these Regulations, or by any provision of the Act as applied by these Regulations, on a person or body other than the licensing authority.
Traditional herbal registrations for traditional herbal medicinal products
4.
—(1) Except in accordance with any exception or exemption set out in the relevant Community provisions and subject to paragraphs 2, 4 and 5 of Schedule 1—
unless a traditional herbal registration in respect of that product has been granted in accordance with the relevant Community provisions by the licensing authority and is for the time being in force in accordance with those provisions.
(2) Schedule 1 shall have effect for the purpose of making certain exceptions or exemptions from paragraph (1), and for imposing certain obligations in connection with such exceptions and exemptions.
Applications for the grant or renewal of a traditional herbal registration
5.
—(1) Every application for the grant or renewal of a traditional herbal registration shall be made in writing in accordance with the relevant Community provisions, subject to the rules of Community law relating to parallel imports, and the applicant shall comply with so much of the relevant Community provisions as contain requirements for applications as are applicable to the application or the consideration of it.
(2) Every application shall be made in writing, shall be signed by or on behalf of the applicant and shall, unless the licensing authority otherwise direct, be accompanied by any fee which may be payable in connection with that application.
(3) One copy of the application and of any accompanying material shall be supplied to the licensing authority in the English language and where the application or any accompanying material has been translated from another language, one copy of the application or the accompanying material, as the case may be, shall also be supplied in the original language.
(4) An application for the grant of a traditional herbal registration shall include a statement indicating—
(b) what, if any, provisions of the traditional herbal registration are proposed concerning the method of sale or supply of the product (including, in particular, any proposed restrictions affecting the circumstances of the use or promotion of the product).
(5) The applicant for the grant or renewal of a traditional herbal registration must be established in the Community.
(6) An application for the renewal of a traditional herbal registration shall be made not later than 6 months before the date on which the existing traditional herbal registration expires.
Consideration, and grant or refusal, of an application for, or for renewal or variation of, a traditional herbal registration
6.
—(1) The licensing authority shall—
(2) Schedule 2 shall have effect to regulate the procedure for receiving advice and representations before granting, renewing or varying, or refusing to grant, renew, or vary a traditional herbal registration, or after notification of a decision relating to an application to vary such a registration.
(3) A parallel import licence shall, unless previously renewed or revoked, be valid for the period specified in it, but where an application to renew it is made in accordance with regulation 5(6) it shall remain in force pending the decision of the licensing authority on that application.
(4) Subject to paragraph (6), a traditional herbal registration other than a parallel import licence shall, unless previously revoked, be valid for an unlimited period unless—
(5) Subject to paragraph (6), where, by reason of paragraph (4), a traditional herbal registration is not valid for an unlimited period, it shall, unless previously revoked, be valid for a period of five years beginning with the date on which it is granted or was renewed, whichever is the later, but where an application for its renewal is made in accordance with Article 24 of the 2001 Directive the traditional herbal registration shall remain in force pending the decision of the licensing authority on that application.
(6) A traditional herbal registration (other than a parallel import licence) shall cease to be valid if at any time after it is granted the medicinal product to which it relates is not placed on the market in the United Kingdom for a period of three consecutive years, unless an exemption is granted in accordance with Article 24(6) of the 2001 Directive.
(7) Each traditional herbal registration granted by the licensing authority shall be granted subject to a condition that the traditional herbal medicinal product to which the registration relates is to be available—
Revocation, suspension or variation of a traditional herbal registration or the suspension of the use or marketing of traditional herbal medicinal products
7.
—(1) The licensing authority may and, where appropriate shall, subject to and in accordance with the relevant Community provisions, revoke, suspend or vary a traditional herbal registration for a traditional herbal medicinal product.
(2) The licensing authority may and, where appropriate, shall, subject to paragraph (3) and subject to and in accordance with the relevant Community provisions, by notice in writing to the holder of a traditional herbal registration for a traditional herbal medicinal product, forthwith or from a date specified in the notice, suspend the use, supply or marketing within the United Kingdom of the product to which the registration relates for a period specified in the notice.
(3) In any case where the relevant Community provisions permit or require the suspension of the use, supply or marketing of a product until some decision or similar action is taken by the Community, the licensing authority may, instead of specifying a period in the notice, provide that the suspension is to apply until further notice.
(4) Where the licensing authority, in accordance with paragraph (3), include a provision that the suspension is to apply until further notice, they shall, where the effect of the Community decision or action is that the product may continue to be used or, as the case may be, marketed, in the United Kingdom, promptly give the holder of the registration written notice revoking the suspension forthwith or from such date specified in the notice as to comply with that decision or action.
(5) Where, under the preceding provisions of this regulation the licensing authority revoke or suspend a traditional herbal registration, or where the licensing authority suspend the use, supply or marketing of a product, or where the relevant Community provisions so permit or require, the licensing authority may and, where appropriate, shall give written notice to the person who is or, immediately before its revocation or suspension, was the holder of the registration, requiring him to take all reasonably practicable steps to—
(6) The licensing authority may require the holder of the traditional herbal registration to withdraw from the market in the United Kingdom specified batches only of a product to which a notice under paragraph (5) applies.
(7) Schedule 2 shall have effect to regulate the procedure for receiving advice and representations before revocation, variation or suspension of a traditional herbal registration, and for notifying the holder of that registration in accordance with the preceding provisions of this regulation.
Urgent safety restrictions
8.
—(1) The licensing authority may, subject to and in accordance with the relevant Community provisions, impose an urgent safety restriction on the holder of a traditional herbal registration.
(2) Where the licensing authority imposes an urgent safety restriction in accordance with paragraph (1), the holder of the traditional herbal registration shall—
Obligations of holders of traditional herbal registrations, and offences by holders of traditional herbal registrations and other persons
9.
—(1) Every holder of a traditional herbal registration for a traditional herbal medicinal product shall comply with all obligations which relate to him by virtue of the relevant Community provisions including, in particular, obligations relating to providing or updating information, to making changes, to applying to vary the traditional herbal registration, to pharmacovigilance, and to labels and package leaflets.
(2) The holder of a traditional herbal registration shall maintain a record of reports of which he is aware of suspected adverse reactions in accordance with the relevant Community provisions which shall be open to inspection by a person authorised by the licensing authority, who may take copies of the record and, if the licensing authority so directs, the registration holder shall furnish the licensing authority with a copy of any such reports of which he has a record or of which he is or subsequently becomes aware.
(3) The holder of a traditional herbal registration shall keep such documents as will facilitate the withdrawal or recall from sale or supply of any traditional herbal medicinal product to which the registration relates.
(4) The holder of a traditional herbal registration shall notify the licensing authority if the medicinal product to which the registration relates has not been placed on the market in the United Kingdom for a period of three consecutive years.
(5) The holder of a traditional herbal registration shall, on request from the licensing authority, provide the licensing authority with data on the volume of sales of the medicinal product to which the registration relates.
(6) Schedule 3 shall have effect to create certain criminal offences in connection with the obligations of applicants for, and holders of, traditional herbal registrations and other persons arising under the relevant Community provisions.
(7) Where, by or under any provision of the relevant Community provisions or of these Regulations, a person is required to provide any information or furnish any document to the licensing authority and no time is specified in that provision within which that obligation is to be performed, it shall be performed within such time as may be specified in a written notice served on that person by the licensing authority.
Consequential and other amendments of the Act and other enactments
10.
—(1) Section 7 of the Act (general provisions as to dealing with medicinal products) shall not apply in relation to traditional herbal medicinal products.
(2) Section 23 of the Act (special provisions as to effect of manufacturer's licence) shall have effect as if any reference in subsection (1) to a product licence included a reference to a traditional herbal registration.
(3) Section 56 of the Act (exemptions in respect of herbal remedies) shall not apply in relation to traditional herbal medicinal products.
(4) Section 61 of the Act (special restrictions on persons to be supplied with medicinal products) shall have effect as if the reference to a product licence included a reference to a traditional herbal registration.
(5) The provisions of the Trade Descriptions Act 1968[10] shall apply to the application of a trade description to goods subject to a traditional herbal registration in the same way as, by virtue of section 2(5)(b) of that Act, they apply to the application of a trade description to goods subject to any provision made under Part V of the Act.
(6) Section 1(1) of the Medicines Act 1971[11] (fees payable for purposes of Part II of the Act) shall have effect as if the reference to any application in pursuance of the Act for a licence under Part II of the Act or for the variation or renewal of such a licence included a reference to any application under these Regulations for a traditional herbal registration or for the variation or renewal of such a registration.
(7) Section 19 of the Consumer Protection Act 1987[12] (interpretation of Part II) shall have effect as if in subsection (1) in the definition of "licensed medicinal product", the reference to any medicinal product within the meaning of the Medicines Act 1968 in respect of which a product licence within the meaning of that Act is for the time being in force, included a reference to a traditional herbal medicinal product in respect of which a traditional herbal registration under these Regulations is for the time being in force.
Application of enforcement provisions of the Act
11.
—(1) Subject to paragraph (2) below, the following provisions of Part VIII of the Act (which provide for enforcement of the Act), namely, sections 107 to 109, section 110 except subsection (4), sections 111 to 116, section 118, section 119, sections 121 to 127 and Schedule 3, shall apply for the purposes of these Regulations as they apply for the purposes of the Act.
(2) Those provisions as so applied shall have effect—
Other Schedules to have effect
12.
The following Schedules shall have effect, namely Schedule 5 (labels), Schedule 6 (transitional provision) and Schedule 7 (consequential amendments to orders and regulations).
Signed by authority of the Secretary of State for Health
Warner
Minister of State, Department of Health
6th October 2005
that register;
against whose name is recorded in the relevant register, an annotation or entry signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber.
2.
Regulation 4(1) shall not apply to a traditional herbal medicinal product supplied in response to a bona fide unsolicited order, formulated in accordance with the specification of a doctor, dentist or supplementary prescriber and for use by his individual patients on his direct personal responsibility, in order to fulfil the special needs of those patients, but such supply shall be subject to the conditions specified in paragraph 3.
3.
The conditions mentioned in paragraph 2 are that—
(f) the traditional herbal medicinal product is distributed by way of wholesale dealing by the holder of a wholesale dealer's licence.
4.
—(1) Subject to the following sub-paragraphs, regulation 4(l) shall not apply to anything done—
and consists of procuring the manufacture or assembly of a stock of the product with a view to administering the product to such patients;
(b) in relation to Scotland and Northern Ireland, by a doctor or dentist which relates to a traditional herbal medicinal product specially prepared by him, or to his order, for administration—
and consists of procuring the manufacture or assembly of a stock of the product with a view to administering the product to such patients; or
(c) in a registered pharmacy, a hospital or health centre and is done there by or under the supervision of a pharmacist, and consists of procuring the manufacture or assembly of a stock of traditional herbal medicinal products with a view to dispensing them in accordance with paragraph 2.
(2) The exemption conferred by sub-paragraph (1) shall not apply to procuring the manufacture of traditional herbal medicinal products unless those products are to be manufactured by the holder of a manufacturer's licence which relates specifically to the manufacture or assembly of traditional herbal medicinal products to which paragraph 2 applies.
(3) The exemption conferred by sub-paragraph (1) shall not apply to anything done by a doctor or dentist in relation to a stock held by him of such traditional herbal medicinal products in excess of a total of 5 litres of fluid and 2.5 kilograms of solids of all traditional herbal medicinal products to which that sub-paragraph relates.
5.
—(1) Regulation 4(1) shall not apply to the placing on the market by way of supplying of any traditional herbal medicinal product to which this paragraph relates if the conditions of sub-paragraph (2) are satisfied.
(2) The conditions referred to in sub-paragraph (1) are—
6.
Any person who sells or supplies a traditional herbal medicinal product in accordance with any of paragraphs 2 to 5 shall maintain, and keep for a period of at least 5 years, a record showing—
7.
A person required to maintain the records mentioned in paragraph 6 shall—
Scope and application of this Schedule
2.
Subject to paragraphs 6 and 7, Part 2 applies to—
3.
Subject to paragraphs 6 and 7, Part 3 applies to any application to vary a traditional herbal registration for a traditional herbal medicinal product which is a complex or a new excipient variation application.
4.
Subject to paragraphs 6 and 7, Part 4 applies where the licensing authority propose to refer an application for the grant of a traditional herbal registration for a traditional herbal medicinal product to the Committee for Herbal Medicinal Products in accordance with Article 16c(4) of the 2001 Directive.
5.
Subject to paragraphs 6 and 7, Part 5 applies where—
gives notice under paragraphs 12, 17 or 20 of his wish to appear before or be heard by a person appointed by the licensing authority.
6.
This Schedule shall cease to apply if at any time the relevant matter is, by virtue of any relevant Community provision, referred to the Committee for Herbal Medicinal Products for the application of the procedure laid down in Articles 32 to 34 of the 2001 Directive.
7.
This Schedule does not apply—
(b) if the application or proposal relates to the renewal, revocation, suspension or variation of a traditional herbal registration which has been granted—
(c) if the licensing authority refuse to grant the traditional herbal registration applied for following a referral to the Committee for Herbal Medicinal Products in accordance with Article 16c(4) where the Committee for Herbal Medicinal Products has not supported the grant of the application.
on grounds relating to safety, quality or efficacy, except after consultation with the appropriate committee.
Provisional opinion against traditional herbal registration
9.
—(1) Where the appropriate committee are consulted under the preceding paragraph and are of the provisional opinion that, on grounds relating to safety, quality or efficacy, they—
the appropriate committee shall notify the applicant or holder accordingly.
(2) A person who has been so notified may, within the time allowed, give notice of his wish to make written or oral representations to the appropriate committee.
(3) The appropriate committee shall give the applicant or holder an opportunity to make such representations in accordance with sub-paragraphs (4) to (7).
(4) Subject to sub-paragraph (5), the applicant or holder shall provide the appropriate committee with—
before the end of the period of six months beginning with the date of the notice referred to in sub-paragraph (2), or within such shorter period as the appropriate committee may specify in the notification under sub-paragraph (1).
(5) If the applicant or holder so requests, the appropriate committee may extend the time limit referred to in sub-paragraph (4), up to a maximum period of twelve months beginning with the date of the notice referred to in sub-paragraph (2).
(6) The applicant or holder may not submit any additional written representations or documents once the time limit referred to in sub-paragraphs (4) and (5) has expired, except with the permission of the appropriate committee.
(7) If the applicant or holder gave notice of his wish to make oral representations, the appropriate committee shall, after receiving a written summary and any other documents in accordance with sub-paragraph (4), arrange for the applicant or holder to make such representations at a hearing before the committee.
(8) The appropriate committee shall—
Licensing authority's decision after appropriate committee report
10.
—(1) After receiving the report of the appropriate committee pursuant to paragraph 9(8) the licensing authority shall—
(2) The licensing authority shall then notify the applicant or holder of–—
Licensing authority proposals in other cases
11.
—(1) If—
the licensing authority shall notify the applicant or holder accordingly.
Right to be heard by a person appointed or to make further representations
12.
—(1) Subject to sub-paragraph (4), a person to whom a notification has been given under paragraph 10(2) may, within the time allowed, notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority with respect to the decision.
(2) A person to whom a notification has been given under paragraph 11(1) or (2) may, within the time allowed—
(3) If the applicant makes written representations in accordance with sub-paragraph (2)(b) of this paragraph, the licensing authority shall take those representations into account before determining the matter.
(4) Sub-paragraph (1) shall not apply where—
Cases where suspension is to have immediate effect
13.
—(1) Paragraph 8 shall not apply to the suspension of a traditional herbal registration (whether or not it applies to any existing proposal to suspend or revoke the traditional herbal registration) where it appears to the licensing authority that, in the interests of safety, it is necessary to suspend the traditional herbal registration with immediate effect for a period not exceeding three months.
(2) Where the licensing authority so suspend a traditional herbal registration they shall report the suspension forthwith to the appropriate committee.
14.
If, after suspending a traditional herbal registration with immediate effect by virtue of paragraph 13—
that the traditional herbal registration ought to be further suspended, or ought to be varied or revoked, the licensing authority shall proceed in accordance with the applicable provisions of this Schedule (including paragraph 13).
they shall notify the applicant accordingly.
(2) A person who has been notified in accordance with sub-paragraph (1) may, within the time allowed, give notice to the licensing authority of his wish to make written or oral representations to the appropriate committee.
(3) On receipt of a notice under sub-paragraph (2), the licensing authority shall inform the appropriate committee and the committee shall give the applicant an opportunity to make such representations in accordance with sub-paragraphs (4) to (7).
(4) Subject to sub-paragraph (5), the applicant shall provide the appropriate committee with—
before the end of the period of six months beginning with the date of the notice referred to in sub-paragraph (1), or within such shorter period as the licensing authority may specify in the notification referred to in sub-paragraph (1).
(5) If the applicant so requests, the appropriate committee may extend the time limit referred to in sub-paragraph (4), up to a maximum period of twelve months beginning with the date of the notice referred to in sub-paragraph (2).
(6) The applicant may not submit any additional written representations or documents once the time limit referred to in sub-paragraphs (4) and (5) has expired, except with the permission of the appropriate committee.
(7) If the applicant gave notice of his wish to make oral representations, the appropriate committee shall, after receiving a written summary and any other documents in accordance with sub-paragraph (4), arrange for the applicant to make such representations at a hearing before the committee.
(8) The appropriate committee shall—
Licensing authority decision
16.
—(1) After receiving the report of the appropriate committee, the licensing authority shall—
(2) The licensing authority shall notify the applicant of—
Right to be heard by a person appointed
17.
—(1) Subject to sub-paragraph (2), if the licensing authority notify the applicant of the authority's decision—
the applicant may, within the time allowed, notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority with respect to the decision.
(2) Sub-paragraph (1) shall not apply where—
before the end of the period of six months beginning with the date of the notice referred to in sub-paragraph (1), or within such shorter period as the licensing authority may specify in the notification referred to in sub-paragraph (1).
(5) If the applicant so requests, the appropriate committee may extend the time limit referred to in sub-paragraph (4), up to a maximum period of twelve months beginning with the date of the notice referred to in sub-paragraph (2).
(6) The applicant may not submit any additional written representations or documents once the time limit referred to in sub-paragraphs (4) and (5) has expired, except with the permission of the appropriate committee.
(7) If the applicant gave notice of his wish to make oral representations, the appropriate committee shall, after receiving a written summary and any other documents in accordance with sub-paragraph (4), arrange for the applicant to make such representations at a hearing before the committee.
(8) The appropriate committee shall—
Licensing authority decision
19.
—(1) After receiving the report of the appropriate committee, the licensing authority shall—
(2) The licensing authority shall notify the applicant of—
Right to be heard by a person appointed
20.
—(1) Subject to sub-paragraph (2), if the licensing authority notify the applicant of the authority's decision to refer the application to the Committee for Herbal Medicinal Products as proposed, the applicant may, within the time allowed, notify the licensing authority that he wishes to appear before and be heard by a person appointed by the licensing authority with respect to the decision.
(2) Sub-paragraph (1) shall not apply where—
(2) The person appointed—
(b) shall not be an officer or servant of a Minister of the Crown.
(3) Subject to sub-paragraph (4), the applicant or holder shall provide the person appointed with—
before the end of the period of three months beginning with the date of the notice referred to in sub-paragraph (1).
(4) If the applicant or holder so requests, the person appointed may, after consulting the licensing authority, extend the time limit referred to in sub-paragraph (3), up to a maximum period of six months beginning with the date of the notice referred to in sub-paragraph (1).
(5) If the applicant or holder fails to comply with the time limit in sub-paragraph (3) or, where he has been granted an extended time limit under sub-paragraph (4), that time limit—
as the case may be.
(6) The applicant or holder may not submit any additional written representations or documents once the time limit has expired, except with the permission of the person appointed.
(7) At the hearing before the person appointed, both the applicant or holder and the licensing authority may make representations.
(8) If the applicant or holder so requests the hearing shall be in public.
(9) After the hearing—
as the case may be.
(10) The licensing authority shall then—
shall be guilty of an offence.
8.
Any holder of a traditional herbal registration who fails to forward to the licensing authority any data requested by the authority pursuant to the final paragraph of Article 23 of the Directive—
shall be guilty of an offence.
9.
Any holder of a traditional herbal registration who fails to forward to the licensing authority any data requested by the authority pursuant to regulation 9(5)—
shall be guilty of an offence.
10.
Any person who is the holder of a traditional herbal registration who fails to ensure appropriate and continued supplies pursuant to the second paragraph of Article 81 of the 2001 Directive shall be guilty of an offence.
11.
Any holder of a traditional herbal registration who communicates to the general public information relating to pharmacovigilance concerns about the product to which the registration relates without having previously communicated, or without simultaneously communicating, such information to the licensing authority shall be guilty of an offence.
12.
Any holder of a traditional herbal registration who fails to ensure that information relating to pharmacovigilance concerns about the product to which the registration relates which he communicates to the general public or the licensing authority is presented objectively and is not misleading shall be guilty of an offence.
13.
Any person responsible for placing on the market a traditional herbal medicinal product authorised by the licensing authority who, at any time, does not have at his disposal an appropriately qualified person responsible for pharmacovigilance as required by Title IX of the 2001 Directive shall be guilty of an offence.
14.
Any person responsible for placing a traditional herbal medicinal product on the market who fails to report to the licensing authority any suspected adverse reaction, or to submit to the licensing authority any records of suspected adverse reactions as required by Title IX of the 2001 Directive, shall be guilty of an offence.
15.
Any person responsible for placing a traditional herbal medicinal product on the market who fails to make or maintain a detailed record of any suspected adverse reaction as required by Title IX of the 2001 Directive shall be guilty of an offence.
16.
Any person who, while employed or engaged as an appropriately qualified person responsible for pharmacovigilance for the purposes of Title IX of the 2001 Directive fails to—
as required by any provision of that Title, shall be guilty of an offence.
17.
—(1) Any person who in the course of an application for the grant, renewal or variation of a traditional herbal registration for a traditional herbal medicinal product—
shall be guilty of an offence.
(2) Any person who—
who provides to the licensing authority any information which is relevant to an evaluation of the safety, quality or efficacy of the traditional herbal medicinal product but which is false or misleading in a material particular shall be guilty of an offence.
18.
Any holder of a traditional herbal registration who sells or supplies or procures the sale or supply of a traditional herbal medicinal product to which the traditional herbal registration relates—
the applicable requirements of Title V of the 2001 Directive or of Schedule 5 to these Regulations, shall be guilty of an offence.
19.
Where, in relation to a traditional herbal medicinal product —
the applicable requirements of Title V of the 2001 Directive or Schedule 5, any person, other than the holder of the traditional herbal registration for that product, who in the course of a business carried on by him, sells or supplies or procures the sale or supply of that product knowing, or having reasonable cause to believe, that the labelling does not so comply or, as the case may be, that the product is not so accompanied, shall be guilty of an offence.
20.
Any person who fails to keep any record required under paragraph 6 of Schedule 1, or to give notice or make it available for inspection as and when required under paragraph 7 of that Schedule, shall be guilty of an offence.
21.
Any person who—
who provides to the licensing authority any information which is relevant to an evaluation of the safety, quality or efficacy of the traditional herbal medicinal product but which is false or misleading in a material particular shall be guilty of an offence.
Penalties
22.
Any person guilty of an offence under any of the preceding paragraphs shall be liable—
Miscellaneous
23.
—(1) Where an offence is committed under any of paragraphs 14, 15, 16 or 17 by a person mentioned in those paragraphs who is acting as the employee or agent of another person, the employer or principal of that person shall be guilty of the same offence.
(2) Where a Scottish partnership is guilty of an offence under these Regulations in respect of any act or default which is shown to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a partner in the partnership, he, as well as the partnership, shall be guilty of that offence and shall be liable to be proceeded against and punished accordingly.
24.
Where the holder of a traditional herbal registration is charged with an offence under these Regulations in respect of anything which has been manufactured or assembled to his order by another person and had been so manufactured or assembled as not to comply with the provisions of that registration, it shall be a defence for him to prove—
25.
—(1) A person does not commit an offence under paragraphs 10, 17 or 21 if he took all reasonable precautions and exercised all due diligence to avoid the commission of that offence.
(2) Where evidence is adduced which is sufficient to raise an issue with respect to that defence, the court or jury shall assume that the defence is satisfied unless the prosecution proves beyond reasonable doubt that it is not.
2.
In section 108 (enforcement in England and Wales)—
3.
In section 109 (enforcement in Scotland), for subsections (1) to (3), substitute—
4.
For section 110 (enforcement in Northern Ireland) substitute—
5.
In section 111 (rights of entry)—
6.
In section 112 (power to inspect, take samples and seize goods and documents)—
is", and
(c) in subsection (5), for "this Act and any regulations or order made thereunder" substitute "the Herbal Regulations";
(d) in subsection (7)—
(e) in subsection (9), for "this Act", in the second place those words appear, substitute "the Herbal Regulations".
7.
In section 115 (analysis of samples in other cases)—
8.
In section 116 (liability to forfeiture under Customs and Excise Management Act 1979)—
9.
In section 118 (restrictions on disclosure of information), in subsection (1)(b), for "this Act" substitute "the Herbal Regulations or any provision of this Act applied by regulation 11 of those Regulations".
10.
In section 119 (protection for officers of enforcement authorities)—
(b) in subsection (2)—
(c) in subsection (3), for "this Act" substitute "relevant legislation"; and
(d) after subsection (3) insert—
11.
In section 121 (contravention due to default of other person)—
12.
In section 122 (warranty as defence)—
13.
In section 124 (offences by bodies corporate)—
14.
In section 125 (prosecutions)—
15.
In section 127 (service of documents)—
16.
In Schedule 3 (sampling)—
Introductory
2.
The requirements of this Schedule supplement those of Title V of the 2001 Directive relating to—
Dispensed traditional herbal medicinal products
3.
—(1) Subject to the following provisions of this Schedule, where a traditional herbal medicinal product is a dispensed traditional herbal medicinal product the container of that product shall be labelled to show the following particulars—
or where a pharmacist, in the exercise of his professional skill and judgement, is of the opinion that any of such particulars are inappropriate and has taken such steps as in all the circumstances are reasonably practicable to consult with the practitioner but has been unable to do so, particulars of the same kind as those requested by the practitioner as appear to the pharmacist to be appropriate.
(2) Where the container of a dispensed traditional herbal medicinal product is enclosed in a package immediately enclosing that container the particulars set out in sub-paragraph (1) may be omitted from the container if that package is labelled to show such particulars.
(3) Where a number of containers or packages, or of containers and packages, of dispensed traditional herbal medicinal products all of the same description are enclosed in a package, sub-paragraph (1)(d) shall be deemed to have been complied with if such of the particulars referred to in that sub-paragraph as would, apart from this sub-paragraph, be required to be shown on each container or package, or on each container and package so enclosed, are shown on either one or more such containers or packages or such containers and packages as the case may be.
Traditional herbal medicinal products not on a general sale list
4.
Subject to the following provisions of this Schedule, where a traditional herbal medicinal product to which any of the restrictions imposed by section 52 of the Act (sale or supply of medicinal products not on general sale list) apply is sold by retail, or supplied in circumstances corresponding to retail sale or is offered or exposed for sale by retail, every container and every package immediately enclosing a container of such a product shall unless the product is a dispensed traditional herbal medicinal product, be labelled to show the capital letter "P" within a rectangle within which there shall be no other matter of any kind.
Exemptions
5.
—(1) Nothing in this Schedule shall require the labelling of—
(2) Where any package immediately enclosing a container as is described in paragraph (1)(d)(ii) is—
the requirement shall be deemed to have been complied with if the said letter is displayed at frequent intervals on the said sheet or strip of such packages.
2.
In the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980[17], in regulation 5 (restrictions on persons to be supplied with certain medicinal products), in paragraph (1)(a), after "Marketing Authorizations Etc.) Regulations 1994" insert "or the holder of a traditional herbal registration within the meaning of the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005".
3.
—(1) The Medicines (Pharmacy and General Sale-Exemption) Order 1980[18] is amended as follows.
(2) In article 1 (citation, commencement and interpretation), in paragraph (2), after the definition of "supply" insert the following definition—
(3) In article 4A (exemption for the supply of medicinal products by national health service bodies)[19], in paragraph (2)(e), after "marketing authorization" insert ", a traditional herbal registration".
(4) In article 4B (exemption for health professionals who supply medicinal products under a Patient Group Direction in order to assist doctors or dentists in providing national health services)[20], in paragraph (2)(f), after "marketing authorization" insert ", a traditional herbal registration".
(5) In article 4C (exemption for the supply of medicinal products by independent hospitals, clinics and agencies)[21], in paragraph (2)(e), after "marketing authorization" insert ", a traditional herbal registration".
(6) In article 4D (exemption for health professionals who supply medicinal products under a Patient Group Direction in order to assist the provision of health care by or on behalf of the police, the prison services or the armed forces)[22], in paragraph (2)(f), after "marketing authorization" insert ", a traditional herbal registration".
4.
—(1) The Medicines (Products Other Than Veterinary Drugs) (General Sale List) Order 1984[23] is amended as follows.
(2) In article 1 (citation, commencement and interpretation), in paragraph (2)(a)—
(3) In article 2 (general sale list)—
(b) in paragraph (b) after "marketing authorization" insert "or traditional herbal registration".
5.
In the Dangerous Substances and Preparations (Safety) (Consolidation) Regulations 1994[26], in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of "medicinal product", in paragraph (a), after sub-paragraph (i) insert the following sub-paragraph—
6.
In the Medicines (Aristolochia and Mu Tong etc.) (Prohibition) Order 2001[27], in article 4 (Exceptions to the prohibitions imposed by articles 2 and 3), in paragraph (4), after "(Marketing Authorisations Etc.) Regulations 1994" insert ", a traditional herbal registration within the meaning of regulation 2(1) of the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005".
7.
In the Medicines for Human Use (Kava-Kava) (Prohibition) Order 2002[28], in article 3 (Exceptions to the prohibition imposed by article 2), in paragraph (d)—
8.
In the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003[29], in regulation 1 (citation, commencement and interpretation), in paragraph (2)—
(b) in the definition of "the TSE Guideline" after "for human use" insert "as substituted by Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use".
[4] OJ No. L311, 28.11.2001, p.67.back
[5] OJ No. L33, 8.2.2003, p.30.back
[6] OJ No. L159, 27.6.2003, p.46.back
[7] OJ No. L136, 30.4.2004, p.85.back
[8] OJ No. L136, 30.4.2004, p.34.back
[11] 1971 c.69; section 1 was amended by section 21(1) of the Health and Medicines Act 1988 (c.49).back
[17] S.I. 1980/1923, paragraph (1) of regulation 5 was amended by S.I. 1994/3142 and 3144.back
[18] S.I. 1980/1924; relevant amending instruments are S.I. 2000/1919 and 2003/697.back
[19] Article 4A was inserted by article 2(c) of S.I. 2000/1919.back
[20] Article 4B was inserted by article 2(c) of S.I. 2000/1919.back
[21] Article 4C was inserted by article 3 of S.I. 2003/697.back
[22] Article 4D was inserted by article 3 of S.I. 2003/697.back
[23] S.I. 1984/769; relevant amending instrument is S.I. 2002/933.back
[24] The definition of "marketing authorization" was inserted by article 2(a) of S.I. 2002/933.back
[25] OJ No. L136, 30.4.2004, p.1.back
[26] S.I. 1994/2844, regulation 1(2) was amended by S.I. 1996/2635 and 2004/1031.back
[29] S.I. 2003/1680, regulation 1(2) was amended by S.I. 2004/3224.back
[30] Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community code relating to medicinal products for human use, OJ L311, 28.11.2001, p 67.back
[31] OJ No. L136, 30.4.2004, p.85.back