United Kingdom Statutory Instruments

(a) the advice of the appropriate committee, if any, and the reasons stated by the committee for any such advice; and

(b) the proposals of the licensing authority and the reasons for them.

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—

(a) notify the licensing authority that he wishes to appear before and be heard by a person appointed for the purpose by the licensing authority, or

(b) make representations in writing to the licensing authority with respect to the proposal referred to in the notification.

    (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—

(a) the person has not made any representations in accordance with paragraph 9(4) to (7); and

(b) the decision of the licensing authority was in accordance with the advice of the appropriate committee.

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—

(a) it appears to the licensing authority; or

(b) the appropriate committee advise,

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).

(a) to refuse to grant a complex variation application or a new excipient variation application; or

(b) to grant it otherwise than in accordance with the application,

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—

(a) his written representations or a written summary of the oral representations he intends to make; and

(b) any documents on which he wishes to rely in support of those representations,

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—

(a) take into account such representations as are made in accordance with this section; and

(b) report their findings and advice to the licensing authority, together with the reasons for their advice.

Licensing authority decision
     16. —(1) After receiving the report of the appropriate committee, the licensing authority shall—

(a) confirm or alter their decision; and

(b) take the report into account before doing so.

    (2) The licensing authority shall notify the applicant of—

(a) the decision made pursuant to sub-paragraph (1); and

(b) the advice given to them by the appropriate committee and the reasons for that advice.

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—

(a) to refuse the application; or

(b) to grant it otherwise than in accordance with the application,

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—

(a) the person had not made any representations in accordance with paragraph 15(4) to (7); and

(b) the decision of the licensing authority was in accordance with the advice of the appropriate committee.

(a) his written representations or a written summary of the oral representations he intends to make; and

(b) any documents on which he wishes to rely in support of those representations,

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—

(a) take into account such representations as are made in accordance with this section; and

(b) report their findings and advice to the licensing authority, together with the reasons for their advice.

Licensing authority decision
     19. —(1) After receiving the report of the appropriate committee, the licensing authority shall—

(a) decide whether to proceed with their proposal; and

(b) take the report into account before doing so.

    (2) The licensing authority shall notify the applicant of—

(a) the decision made pursuant to sub-paragraph (1); and

(b) the advice given to them by the appropriate committee and the reasons for that advice.

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—

(a) the person had not made any representations in accordance with paragraph 18(4) to (7); and

(b) the decision of the licensing authority was in accordance with the advice of the appropriate committee.

(a) make that appointment; and

(b) arrange for the applicant or holder to have an opportunity of appearing before that person.

    (2) The person appointed—

(a) shall not be, or at any time have been, a member of—


(i) the Commission on Human Medicines or any of its Expert Advisory Groups,

(ii) the Medicines Commission formerly established under section 2 of the Act or any of its committees, or

(iii) a committee established under section 4 of the Act, or any sub-committee of such a committee; and



(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—

(a) a written summary of the oral representations he intends to make; and

(b) any documents on which he wishes to rely in support of those representations,

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—

(a) he may not appear before or by heard by the person appointed; and

(b) the licensing authority shall decide whether—


(i) to confirm or alter their decision,

(ii) to refer the application to the Committee for Herbal Medicinal Products,

(iii) to grant or renew the traditional herbal registration,

(iv) to grant or renew the traditional herbal registration otherwise than in accordance with the application, or

(v) to revoke, vary or suspend the traditional herbal registration,



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—

(a) the person appointed shall provide a report to the licensing authority; and

(b) the licensing authority shall take this report into account and decide whether—


(i) to confirm or alter their decision,

(ii) to refer the application to the Committee for Herbal Medicinal Products,

(iii) to grant or renew the traditional herbal registration,

(iv) to grant or renew the traditional herbal registration otherwise than in accordance with the application, or

(v) to revoke, vary or suspend the traditional herbal registration,



as the case may be.

    (10) The licensing authority shall then—

(a) notify the applicant or holder of their decision;

(b) if the applicant or holder so requests, provide the applicant or holder with a copy of the report of the person appointed.

(a) take any steps reasonably necessary to take account of technical and scientific progress for the purposes of making any changes or amendments as required by Article 23 of the 2001 Directive; or

(b) introduce any changes or make any amendments that may be required in accordance with that Article or paragraphs 3.2(9) and 3.2.2.4(c) of Part I of Annex I to the 2001 Directive; or

(c) provide information to the licensing authority as required by the third or fourth paragraphs of Article 23 of the 2001 Directive; or

(d) submit any application to the licensing authority to make any changes or variation as required by that Article; or

(e) notify the licensing authority if the traditional herbal 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 pursuant to regulation 9(4);

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—

(a) where the licensing authority have served a written notice on the holder under regulation 9(7) in relation to the request, within the time specified in that notice;

(b) where there is no such notice, promptly,

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)—

(a) where the licensing authority have served a written notice on the holder under regulation 9(7) in relation to the request, within the time specified in that notice;

(b) where there is no such notice, promptly,

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—

(a) establish or maintain a system for collecting and collating information about suspected adverse reactions;

(b) prepare for the licensing authority a report on any such reactions; or

(c) ensure that a request from the licensing authority for the provision of additional information necessary for the evaluation of the benefits and risks afforded by a traditional herbal medicinal product is answered fully and promptly; or

(d) provide to the licensing authority any other information relevant to the evaluation of the benefits and risks afforded by a medicinal product, including appropriate information on post authorization safety studies,

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—

(a) fails to provide to the licensing authority any information which is relevant to an evaluation of the safety, quality or efficacy of the traditional herbal medicinal product as required by point (7) or (11) of the introduction to Annex I to the 2001 Directive; or

(b) 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.

    (2) Any person who—

(a) is responsible for placing a traditional herbal medicinal product on the market;

(b) is the traditional herbal registration holder for a traditional herbal medicinal product; or

(c) while employed or engaged as an appropriately qualified person responsible for pharmacovigilance for the purposes of Title IX of the 2001 Directive is required to provide information to the licensing authority about a traditional herbal medicinal product,

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—

(a) the labelling of which, or any package leaflet accompanying which, does not comply with; or

(b) without a package leaflet required to be provided by virtue of,

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 —

(a) the labelling of the product, or any package leaflet accompanying the product, does not comply with; or

(b) the product is not accompanied by a package leaflet required to be provided by virtue of,

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—

(a) sells or supplies a traditional herbal medicinal product in accordance with any of paragraphs 2 to 5 of Schedule 1; or

(b) provides a specification for such a product for the purposes of paragraph 2 of that Schedule,

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—

(a) on summary conviction, to a fine not exceeding the statutory maximum;

(b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.

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—

(a) that he had communicated the provisions relating to the registration to that other person; and

(b) that he did not know, and could not by the exercise of reasonable care have known, that those provisions had not been complied with.

     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.

(a) in subsection (1), for "Part II of this Act or of a Minister under section 75 of this Act, and the validity of any licence or certificate" substitute "the Herbal Regulations, and the validity of any registration";

(b) in subsections (2)(a) and (3)(b), for "this Act" substitute "the Herbal Regulations";

(c) in subsection (2)(b), for "this Act or of any regulations made under this Act" substitute "the Herbal Regulations"; and

(d) in subsection (4), for "licence or certificate", in each place those words appear, substitute "registration".

     2. In section 108 (enforcement in England and Wales)—

(a) for subsection (1) substitute—

    " (1) It shall be the duty of the Secretary of State to enforce in England, or to secure the enforcement in England of, the provisions of the Herbal Regulations.

    (1A) It shall be the duty of the National Assembly of Wales to enforce in Wales, or to secure the enforcement in Wales of, the provisions of the Herbal Regulations."; and

(b) in subsection (2)(c) after "this Act", in the second place those words appear, insert "or the Herbal Regulations".

     3. In section 109 (enforcement in Scotland), for subsections (1) to (3), substitute—

    " (1) It shall be the duty of the Scottish Ministers to enforce in Scotland, or to secure the enforcement in Scotland of, the provisions of the Herbal Regulations.".

     4. For section 110 (enforcement in Northern Ireland) substitute—

" It shall be the duty of the Department for Health, Social Services and Public Safety to enforce in Northern Ireland, or to secure the enforcement in Northern Ireland of, the provisions of the Herbal Regulations.".

     5. In section 111 (rights of entry)—

(a) in subsection (1)(a), for the words after "contravention" substitute "of any provisions of the Herbal Regulations, or";

(b) in subsection (1)(b), for "this Act or under any such regulations or order" substitute "those Regulations or any of the provisions of this Act applied by regulation 11 of those Regulations";

(c) in subsection (2)(a), for the words from "this Act or of any regulations" onwards substitute "the Herbal Regulations;"; and

(d) in subsection (3)—


(i) for "licence or certificate under Part II of this Act" substitute "registration under the Herbal Regulations", and

(ii) for "licence or certificate", in the second place those words appear, substitute "registration".

     6. In section 112 (power to inspect, take samples and seize goods and documents)—

(a) in subsection (1), for the words before paragraph (a) substitute—

" For the purpose of ascertaining whether there is or has been a contravention of the Herbal Regulations, any person duly authorised in writing by an enforcement authority shall have a right to inspect—";

(b) in subsection (4)—


(i) for "offence under this Act is" substitute—

" offence—
(a) under the Herbal Regulations, or

(b) under section 114, 118 or 123 of this Act,



is", and

(ii) for "under this Act", in the second place those words appear, substitute "under those Regulations or under any of the provisions of this Act applied by regulation 11 of those Regulations";



(c) in subsection (5), for "this Act and any regulations or order made thereunder" substitute "the Herbal Regulations";

(d) in subsection (7)—



(i) for "a licence or certificate under Part II of this Act" substitute "a registration under the Herbal Regulations", and

(ii) for "licence or certificate", in the second place those words appear, substitute "registration"; and



(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)—

(a) in subsection (7), for "form prescribed by the Ministers" substitute "prescribed form"; and

(b) omit subsection (9).

     8. In section 116 (liability to forfeiture under Customs and Excise Management Act 1979)—

(a) for "this Act", in both places those words appear, substitute "the Herbal Regulations"; and

(b) after subsection (3) insert—

    " (4) In this section "the Ministers" means the Secretary of State and the Department for Health, Social Services and Public Safety, acting jointly.".

     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)—

(a) in subsection (1)—


(i) for "this Act", in the first place those words appear, substitute "relevant legislation", and

(ii) for "this Act", in the second place those words appear, substitute "that legislation";



(b) in subsection (2)—



(i) for "this Act", in the first place those words appear, substitute "relevant legislation", and

(ii) for "this Act", in the second place those words appear, substitute "that legislation";



(c) in subsection (3), for "this Act" substitute "relevant legislation"; and

(d) after subsection (3) insert—

    " (4) In this section "relevant legislation" means—


(a) the Herbal Regulations, or

(b) any provision of this Act applied by regulation 11 of those Regulations.".

     11. In section 121 (contravention due to default of other person)—

(a) in subsection (1), for "to which this section applies constitutes an offence under this Act" substitute "of the Herbal Regulations constitutes an offence under those Regulations";

(b) in subsection (2), for "this Act in respect of a contravention of a provision to which this section applies" substitute "the Herbal Regulations in respect of a contravention of a provision of those Regulations"; and

(c) Omit subsection (4).

     12. In section 122 (warranty as defence)—

(a) in subsection (1), for "this Act in respect of a contravention of a provision to which this section applies" substitute "the Herbal Regulations"; and

(b) Omit subsection (2).

     13. In section 124 (offences by bodies corporate)—

(a) in subsection (1), for "this Act" substitute "the Herbal Regulations, or under section 114, 118 or 123 of this Act,"; and

(b) after subsection (2) insert the following subsection—

    " (2A) In subsections (1) and (2) of this section "body corporate" includes a Scottish partnership and "director", in relation to such a partnership, includes any of its partners".

     14. In section 125 (prosecutions)—

(a) in subsections (1) and (2), for "under this Act" substitute "under the Herbal Regulations, or for an offence under section 114, 118 or 123 of this Act,";

(b) omit subsection (3);

(c) in subsection (4) after "this Act", in the second place those words appear, insert "or under the Herbal Regulations"; and

(d) omit subsections (6) and (7).

     15. In section 127 (service of documents)—

(a) for "any provision of this Act" substitute "relevant legislation"; and

(b) at the end add—

" In this section "relevant legislation" means any provision of the Herbal Regulations or any provision of this Act applied by regulation 11 of those Regulations".

     16. In Schedule 3 (sampling)—

(a) in paragraph 1(1)(a), for the words from "this Act or of any Regulations" onwards substitute "the Herbal Regulations, or";

(b) in paragraph 1(1)(b), for the words from "of their functions" onwards substitute "(in this Schedule referred to as "the relevant enforcement authority") of their functions under those Regulations or under any provision of this Act applied by regulation 11 of those Regulations,";

(c) in paragraph 19(3), for "form prescribed by the Ministers" substitute "prescribed form";

(d) omit paragraph 20(2); and

(e) in each of paragraphs 21 and 22, for "under this Act" substitute "under the Herbal Regulations, or under section 114, 118 or 123 of this Act,".

(f) in paragraph 24(1), for "under this Act," substitute "under the Herbal Regulations, or under section 114, 118 or 123 of this Act,".

"dispensed traditional herbal medicinal product" means a traditional herbal medicinal product prepared or dispensed in accordance with a prescription given by a practitioner; and

"requirements" includes restrictions.

Introductory
     2. The requirements of this Schedule supplement those of Title V of the 2001 Directive relating to—

(a) special warnings necessary for particular medicinal products;

(b) the legal status for supply to the patient, in accordance with Title VI of the 2001 Directive;

(c) identification and authenticity.

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—

(a) where the traditional herbal medicinal product is for use by being administered to a particular human being, the name of the person to whom the traditional herbal medicinal product is to be administered;

(b) the name and address of the person who sells or supplies the traditional herbal medicinal product;

(c) the date on which the traditional herbal medicinal product is dispensed; and

(d) where the traditional herbal medicinal product has been prescribed by a practitioner, such of the following particulars as he may request—


(i) the name of the traditional herbal medicinal product or its common name,

(ii) directions for use of the traditional herbal medicinal product, and

(iii) precautions relating to the use of the traditional herbal medicinal product,



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—

(a) any package in the form of a transparent wrapping or cover to a container and package of a traditional herbal medicinal product or any package the whole or part of which is transparent or open if the particulars shown on the labelled container enclosed in that package are clearly visible;

(b) any package in the form of a wrapping paper, paper bag or similar covering in which the container and package of a traditional herbal medicinal product labelled in accordance with the provisions of this Schedule is placed when such traditional herbal medicinal product is sold by retail or supplied in circumstances corresponding to retail sale;

(c) any container or package immediately enclosing the container of a traditional herbal medicinal product which is for export; or

(d) any container which is—


(i) an ampoule or other container of not more than 10 millilitres nominal capacity which is immediately enclosed in a package which is labelled in accordance with paragraph 4, or

(ii) in the form of a wrapper consisting of paper, film, plastic material, metal foil or other sheet or strip material or in the form of a bubble, blister or other sealed unit consisting of such sheet or strip material, enclosing one or more dosage units of a traditional herbal medicinal product and such container is immediately enclosed in a package which is labelled in accordance with paragraph 4.

    (2) Where any package immediately enclosing a container as is described in paragraph (1)(d)(ii) is—

(a) itself in the form of a bubble, blister or other sealed unit as is mentioned in that paragraph;

(b) part of a continuous series comprising a sheet or strip of like packages; and

(c) required to be labelled to show the letter referred to in paragraph 4,

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.