STATUTORY INSTRUMENTS
2005 No. 2750
MEDICINES
The Medicines
(Traditional Herbal Medicinal
Products for Human Use)
Regulations 2005
Made - - - - - 6th October 2005
Laid before Parliament 7th October 2005Coming 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
£5.50 
 STATUTORY INSTRUMENTS 
2005 No. 2750 
MEDICINES 
The Medicines (Traditional Herbal Medicinal Products for 
Human Use) Regulations 2005 
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 
The Secretary of State, bei ng a Minister designated( a) for the purposes of section 2(2) of the 
European Communities Act 1972( b) in relation to medicinal products, in exercise of the powers 
conferred by the said section 2(2), makes the following Regulations— 
Citation, commencement and extent 
1. These Regulations may be cited as the Medici nes (Traditional Herbal Medi cinal Products for 
Human Use) Regulations 2005 and shall come into force— 
(a) except for the purposes of paragraphs 4(2)(a) and 8(a)(i) of Schedule 7 on 30th October 
2005; and 
(b) for the purposes of paragraphs 4(2)(a) and 8(a)(i) of Schedule 7 on 20th November 2005. 
Interpretation 
2.—(1) In these Regulations— 
“the Act” means the Medicines Act 1968( c); 
“appropriate committee”, for the purposes of any provision of these Regulations under which 
a function falls to be performed, means— 
(a) in a case where— 
(i) a committee has been established under section 4 of the Act for purposes which 
consist of or include any of those specified in subsecti on (3) of that section, and 
(ii) the authority performing that function c onsiders it to be the appropriate committee in 
the circumstances, 
that committee; and 
                                                                                                                                                               
 
(a) S.I. 1972/1811. 
(b) 1972 c.68. 
(c) 1968 c.67.  
 2(b) in any other case, the Commission; 
“the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the 
Council on the Community code relati ng to medicinal products for human use( a) as amended 
by— 
(c) Directive 2002/98/EC of the European Parliament and of the Council setting standards of 
quality and safety for the collection, te sting, processing, storage and distribution of 
human blood and blood components( b), 
(d) Commission Directive 2003/63/ EC amending Directive 2001/83/EC on the Community 
code relating to medi cinal products for human use( c), 
(e) Directive 2004/24/EC of the European Parliament and of the Council amending, as 
regards traditional herbal medici nal products, Directive 2001/83/EC on the Community 
code relating to medi cinal products for human use( d), and 
(f) Directive 2004/27/EC of the European Parliament and of the Council amending Directive 
2001/83/EC on the Community code rela ting to medicinal products for human use( e); 
“EEA State” means a Member State, Norway , Iceland or Liechtenstein; 
“EC traditional herbal registration” means a tr aditional herbal regist ration granted by a 
competent authority of an EEA State in accordance with the simplified registration procedure for traditional herbal medicinal  products set out in Chapter 2a of the 2001 Directive; 
“licensing authority” shall be construed in accordance with section 6 of the Act; 
“parallel import licence” means a traditional herbal registration granted by the licensing 
authority under these Regulations in respect of a traditional herbal medicinal product which is imported into the United Kingdom from another EEA state in accordance with the rules of Community law relating to parallel imports; 
“the relevant Community provisions” means th e provisions of the 2001 Directive which apply 
to traditional herbal medicinal products and to traditional herbal registrations; 
“traditional herbal regist ration” means a registration granted  by the licensing authority under 
these Regulations and includes a parallel import licence. 
(2) Expressions used in these Regulations which are also used in the 2001 Directive shall have 
the same meaning as they have there and rel ated expressions shall be construed accordingly. 
(3) Subject to paragraph (2), section 11 of the Interpretation Act 1978( f) 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 Memb er 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. 
                                                                                                                                                              
 
 
(a) OJ No. L311, 28.11.2001, p.67. 
(b) OJ No. L33, 8.2.2003, p.30. 
(c) OJ No. L159, 27.6.2003, p.46. 
(d) OJ No. L136, 30.4.2004, p.85. 
(e) OJ No. L136, 30.4.2004, p.34. 
(f) 1978 c.30.  
 3Traditional herbal registra tions 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— 
(a) no traditional herbal medi cinal product shall be placed on the market; and 
(b) no such product shall be distributed by way of wholesale dealing, 
unless a traditional herbal registration in respect of that product has been granted in accordance 
with the relevant Community provisions by th e 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 ma king 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 ap plicant shall comply with so much of the 
relevant Community provisions as contain requirem ents for applications as are applicable to the 
application or the consideration of it. 
(2) Every application shall be made in writing, sha ll 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 wh ere 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— 
(a) whether the herbal medici nal product is one that should be available— 
(i) only from a pharmacy; or 
(ii) on general sale; and 
(b) what, if any, provisions of the traditional herbal registration are proposed concerning the 
method of sale or supply of the product (includi ng, 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 traditi onal 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 exi sting 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— 
(a) consider every application for the grant, renewal  or variation by them of a traditional 
herbal registration in accordance with the relevant Community provisions, and (where applicable) the rules of Community law relating to parallel imports, and 
(b) grant, renew or vary, or refuse to grant, renew or vary the registration in accordance with 
those provisions and (where applicable) the rules  of Community law relating to parallel 
imports. 
(2)
 Schedule 2 shall have effect to regulate the procedure for receiving advice and 
representations before granting, renewing or varyi ng, or refusing to grant, renew, or vary a  
 4traditional herbal registration, or after  notification of a decision relati ng 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 th e licensing authority on that application. 
(4) Subject to paragraph (6), a traditional herbal regi stration other than a parallel import licence 
shall, unless previously revoked, be valid for an unlimited period unless— 
(a) it has not been renewed on the basis of a re-evalu ation by the licensing authority of the 
risk-benefit balance in accordance with, and on the basis of the data set out in, Article 24(2) of the 2001 Directive; or 
(b) it has been so renewed, but the licensing authori ty considers on justified grounds relating 
to pharmacovigilance that it should be subject to one additional renewal five years after the date of the first renewal , and it has not yet been subject to that additional renewal. 
(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 registrati on granted by the licensing aut hority shall be granted subject 
to a condition that the traditional herbal medicinal product to which the registration relates is to be 
available— 
(a) only from a pharmacy; or 
(b) on general sale. 
Revocation, suspension or variation of a traditi onal herbal registrati on or the suspension of 
the use or marketing of tradi tional herbal me dicinal products 
7.—(1) The licensing authority may and, where appr opriate shall, subject to and in accordance 
with the relevant Community provisions, re voke, suspend or vary a tradi tional 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 Co mmunity provisions, by notice in writing to the 
holder of a traditional herbal registration for a tr aditional 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 regist ration, or where the licensing aut hority suspend the use, supply 
or marketing of a product, or where the relevant Community provisions so permit or require, the  
 5licensing authority may and, where appropriate, sh all 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— 
(a) inform wholesalers, retailers, medical practitioners,  patients and others who may be in 
possession of relevant products of the revocation or suspension, the reasons for it, and the 
action (if any) to be taken to restri ct or prevent further use, supply or marketing; 
(b) withdraw from the market in the United Kingdom and recover possession of such 
products within the time and for the period specified in the notice.    
(6) The licensing authority may requi re the holder of the traditi onal 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 th e holder of a traditi onal herbal registration. 
(2) Where the licensing authority imposes an urgent safety restriction in accordance with 
paragraph (1), the holder of the traditi onal herbal registration shall— 
(a) implement the restriction within a peri od specified by the licensing authority; and 
(b) apply to vary the registration so as to take account of that safety restriction immediately 
and in any event not later than 15 days after the restriction was imposed. 
Obligations of holders of traditional herb al 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 traditi onal 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 authori sed by the licensing authority, who may take 
copies of the record and, if the licensing authority so directs, the registra tion 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 tr aditional 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 regi stration 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 volu me 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, tr aditional herbal registrations and other persons 
arising under the relevan t Community provisions.  
 6(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 tradi tional herbal medi cinal 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 me dicinal 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( a) 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( b) (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( c) (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— 
(a) with the modifications specified in Schedule 4 to these Regulations; and 
(b) as if all traditional herbal medicinal product s were medicinal products for the purposes of 
the Act (whether or not they would otherwise be so). 
Other Schedules to have effect 
12. The following Schedules shall have effect, namely Schedule 5 (labels), Schedule 6 
(transitional provision) and Schedule 7 (conseq uential amendments to orders and regulations). 
 
                                                                                                                                                               
 
(a) 1968 c.29. 
(b) 1971 c.69; section 1 was amended by section 21(1) of the Health and Medicines Act 1988 (c.49). 
(c) 1987 c.43.  
 7Signed by authority of the Secret ary of State for Health 
 
 
 Warner 
 Minister of State, 
6th October 2005 Department of Health 
 SCHEDULE 1 Regulation 4(2) 
EXEMPTIONS AND EXCEPTIONS FROM THE PROVISIONS OF 
REGULATION 4 
Interpretation 
1. In this Schedule— 
“first level nurse” means a person registered in Sub-Part 1 of the Nurses’ Part of the 
professional register; 
“professional register” means the register maintained by the Nursing and Midwifery Council 
under article 5 of the Nursing and Midwifery Order 2001( a); 
“registered midwife” means a person registered in the Midwives’ Part of the professional 
register; 
“relevant register” means— 
(a) in relation to a first level nurse or registered midwife, the professional register, 
(b) in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the 
Pharmacy Act 1954 or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976, and 
(c) in relation to a person whose name is registered  in the part of the register maintained by 
the Health Professions Council in pursuance of article 5 of the Health Professions Order 2001( b) relating to— 
(i) chiropodists and p odiatrists; 
(ii) physiotherapists; 
(iii) radiographers: diagnostic or therapeutic, 
that register; 
“supplementary prescriber” means— (a) a first level nurse, 
(b) a pharmacist, 
(c) a registered midwife, or 
(d) a person whose name is registered in the part of the register maintained by the Health 
Professions Council in pursuance of article 5 of the Health Professions Order 2001 relating to— 
(i) chiropodists and p odiatrists; 
(ii) physiotherapists; 
(iii) radiographers: diagnostic or therapeutic, 
                                                                                                                                                              
 
 
(a) S.I. 2002/253. 
(b) S.I. 2002/254.  
 8against whose name is recorded in the relevan t 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 traditi onal 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 patient s 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— 
(a) the traditional herbal medicinal  product is supplied to a doctor, dentist or supplementary 
prescriber or for use in a registered pharmacy, a hospital or a health centre under the 
supervision of a pharmacist, in accordance with paragraph 2; 
(b) no advertisement or representation relating to th e traditional herbal medicinal product is 
issued with a view to it being seen generally by the public in the United Kingdom and that no advertisement relating to that product, by means of any catalogue, price list or 
circular letter is issued by, at the request or with  the consent of, the person selling that 
product by retail or by way of wholesale dealing or supplying it in circumstances 
corresponding to retail sale, or the person who manufactures it, and that the supply is in 
response to a bona fide unsolicited order; 
(c) the manufacture or assembly of the traditional  herbal medicinal product is carried out 
under the supervision of such staff and such precautions are taken as are adequate to 
ensure that the product is of the character required by and meets the specifications of the 
doctor, dentist or supplementary prescriber who requires it; 
(d) written records as to the manufacture or assembly in accordance with sub-paragraph (c) 
are made and maintained and are available to the licensing authority or the enforcement 
authority on request by them or either of them; 
(e) if the traditional herbal me dicinal product is manufactured or assembled in the United 
Kingdom, or imported into the United Kingdom from a third country, the product— 
(i) is manufactured, assembled or imported by the holder of a manufacturer’s licence 
which relates specifically to the manufacture, assembly or import of traditional 
herbal medicinal products to wh ich paragraph 2 applies; or 
(ii) has been manufactured, assembled or imported as an investigational medicinal 
product by the holder of a manufacturing aut horization granted by the licensing 
authority for the purposes of regulation 36 of th e Medicines for Human Use (Clinical 
Trials) Regulations 2004( a); and 
(f) the traditional herbal medicinal product is distributed by wa y of wholesale dealing by the 
holder of a wholesale dealer’s licence. 
4.—(1) Subject to the following sub-paragraphs, regulati on 4(l) shall not apply to anything 
done— 
(a) in relation to England and Wales, by a doctor or dentist which relates to a traditional 
herbal medicinal product specially prepared by him, or to his order, for administration— 
(i) to one or more patients of his, or 
(ii) where that doctor or dentist is a member of a group of doctors or dentists working 
together to provide primary medical or general services to one or more patients of 
any other doctor or dentist of that group, 
and consists of procuring the manufacture or assembl y of a stock of the product with a 
view to administering the product to such patients; 
                                                                                                                                                               
 
(a) S.I. 2004/1031.  
 9(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— 
(i) to one or more patients of his, or 
(ii) where that doctor or dentist is a member of a group of doctors or dentists working 
together to provide general medical or dental  services to one or more patients of any 
other doctor or dentist of that group, 
and consists of procuring the manufacture or assembl y of a stock of the product with a 
view to administering th e 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 medi cinal 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 medi cinal 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 medi cinal 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 pl acing on the market by way of supplying of any 
traditional herbal medicinal product to whic h this paragraph relates if the conditions of sub-
paragraph (2) are satisfied. 
(2) The conditions referred to in sub-paragraph (1) are— 
(a) that the traditional herbal me dicinal product is sold or supp lied to a person exclusively for 
use by him in the course of a business carried on by him for the purposes of administering it or causing it to be administered to one or more human beings otherwise than by selling it; 
(b) that, if sold or supplied through the holder of a wholesale dealer’s licence, the traditional 
herbal medicinal product is sold or supplied to  such a person, and for such use by him, as 
is described in head (a) above; 
(c) that, where the manufacture or assembly of the traditional herbal medicinal product is 
procured, it is procured by such a person, and for such use by him, as is described in head (a) above; 
(d) that no advertisement or representation relating to the traditional herbal  medicinal product 
is issued with a view to it being seen generally by the public in the United Kingdom and 
that no advertisement relating to that product, by means of any catalogue, price list or 
circular letter, is issued by, at the request or with  the consent of, the person selling that 
product by retail or by way of wholesale dealing or supplying it in circumstances 
corresponding to retail sale, or the person who manufactures it, and that the supply is in response to a bona fide unsolicited order; 
(e) that the traditional herbal medicinal product is prepared by or under the supervision of a 
pharmacist; and 
(f) that the traditional herbal medicinal  product is manufactured by the holder of a 
manufacturer’s licence which relates specifically to the manufacture of traditional herbal 
medicinal products to which paragraph 2 applies. 
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— 
(a)
 the source from which that person obtained that product;  
 10(b) the person to whom and the date on which the sale or supply was made; 
(c) the quantity of each sale or supply; 
(d) the batch number of the batch of that product  from which the sale or supply was made; 
and 
(e) details of any suspected adverse reaction to the pro duct so sold or supplied of which he is 
aware. 
7. A person required to maintain the records mentioned in paragraph 6 shall— 
(a) notify the licensing authority of any suspected adverse reaction such as is mentioned in 
head (e) of that paragraph which is a serious adverse reaction; and 
(b) make available for inspection at all reasonable times by the licensing authority the records 
mentioned in that paragraph. 
 SCHEDULE 2 Regulations 6(2), 7(7) 
PROCEDURAL PROVISIONS RELATING TO THE GRANT, 
RENEWAL, VARIATION, REVOCATION AND SUSPENSION OF 
TRADITIONAL HERBAL REGISTRATIONS 
PART 1 
INTERPRETATION AND APPLICATION 
Interpretation 
1. In this Schedule— 
“active ingredient from a new source” means an active ingredient in respect of which the 
application names as manufacturer a manufacturer not previously named as the manufacturer 
of that active ingredient included in a medi cinal product in respect of which a marketing 
authorization (other than a product licence of right) or a traditional herbal registration has 
previously been granted; 
“complex variation application” means an a pplication by a traditional herbal registration 
holder to vary a traditional herbal registration which relates to a change in the formulation of a 
medicinal product comprising one or more of the following changes— 
(a) a change in that product’s active ingredients which involves the addition of one or more 
active ingredients which are active ingredients from a new source; 
(b) a change in that product’s excipients which involves the addition of one or more TSE risk 
excipients from a new source; or 
(c) a change which involves the addition of  one or more vitamins or minerals which are 
vitamins or minerals from a new source where no European Pharmacopoeia certificate of suitability covering those vitamins or minerals has been submitted with the application; 
“new excipient” means any ingredient of a medicinal product, other than an active ingredient, 
that has not previously been included in a medi cinal product which is intended to be 
administered by the same route of administrat ion as the product in question and in respect of 
which a marketing authorization (other than a product licence of right) or a traditional herbal 
registration has previously b een granted, except that— 
(a) in the case of a medicinal product intended to be administered orally, the expression does 
not include any ingredient specified in any enactme nt (including an enactment comprised 
in subordinate legislation or in any Di rective, Regulation or Decision of the European 
Community) as an approved ingredient or additive in food or in a food product; and  
 11(b) in the case of a medicinal product intended for external use only, the expression does not 
include any ingredient specified in any enactment (incl uding an enactment comprised in 
subordinate legislation or in any Directiv e, Regulation or Decision of the European 
Community) as an approved ingredient or additive in a cosmetic product; 
“new excipient variation appli cation” means an application, ot her than a complex variation 
application, by a traditional herbal registration holder to vary a traditional herbal registration which relates to a change in the formulation of the medicinal product to add a new excipient; 
“the time allowed” means the period of twenty-eight days beginning with the date of the 
relevant notification, or such longer period as the licensing authority may allow in any 
particular case; 
“TSE risk excipient from a new source” means an excipient which has been manufactured 
from raw materials of ruminant origin or whic h has had raw materials of ruminant origin used 
in its manufacture and in respect of which— 
(a) the application names as manufacturer a manufacturer not previously named as the 
manufacturer of that excipient in cluded in a medicinal product in respect of which a 
marketing authorization (other than a product  licence of right) or a traditional herbal 
registration has previously been granted; and 
(b) no European Pharmacopoeia certificate of suitability covering the excipient has been 
submitted with the application; 
“vitamin or mineral from a new source” means a vitamin or mineral in respect of which the 
application names as manufacturer a manufacturer not previously named as the manufacturer 
of that vitamin or mineral included in a medi cinal product in respect of which a marketing 
authorization (other than a product licence of right) or a traditional herbal registration has 
previously been granted. 
Scope and application of this Schedule 
2. Subject to paragraphs 6 and 7, Part 2 applies to— 
(a) any application for the grant of a traditional  herbal registration for a traditional herbal 
medicinal product except one made pursuant to the procedure in Article 28 of the 2001 
Directive; 
(b) any application to renew a traditional herbal regi stration for a traditi onal herbal medicinal 
product; and 
(c) any proposal to revoke, vary or suspend a traditional herbal registration for a traditional 
herbal medicinal product, other th an a variation on the appli cation of the holder of that 
traditional herbal registration. 
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 tr aditional 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— 
(a) an applicant for a traditional herbal registration for a traditi onal herbal medicinal product, 
or for the variation or renewal of such a traditional herbal registration; or 
(b) the holder of a traditional herbal registration for a traditional herbal medicinal product, 
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.  
 126. This Schedule shall cease to apply if at any time the relevant matter is, by virtue of any 
relevant Community provision, referred to the Commi ttee 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— 
(a) if an application relates to a traditional  herbal medicinal product in respect of which 
either of the conditions set out in Article 16d(1) are fulfilled and— 
(i) the licensing authority declines to assess the application because an application for 
an EC traditional herbal registra tion in another EEA State is being examined in that 
State and the application to the licensi ng authority has not been submitted in 
accordance with Article 28(1) and (3) of the 2001 Directive; or 
(ii) the licensing authority rejects the application where the traditional herbal medicinal 
product in question has an EC traditional herbal registration in another EEA State 
and the application has not been submitted in accordance with Article 28(1) and (2) 
of the 2001 Directive; 
(b) if the application or proposal relates to th e renewal, revocation, suspension or variation of 
a traditional herbal registrat ion which has been granted— 
(i) in accordance with the provisions of Title III, Chapter 4 of the Directive; or 
(ii) which has not been so granted, but whi ch has been subject to the procedure laid 
down in Articles 32 to 34 of the Directive following a referral under Article 30 or 31 
of that Directive, unless the procedure was limited to certain specific parts of the 
traditional herbal registration; or 
(c) if the licensing authority refuse to grant th e 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. 
PART 2 
PROCEDURES RELATING TO GRANT, RENEWAL, COMPULSORY 
VARIATION, REVOCATION OR SUSPENSION OF TRADITIONAL HERBAL 
REGISTRATIONS 
Requirement to consult the appropriate committee 
8. The licensing authority shall not, at any time while this Schedule applies— 
(a) refuse to grant or renew the traditional  herbal registration applied for; or 
(b) revoke, vary or (subject to paragraph 13 of this  Schedule) suspend a traditional herbal 
registration, 
on grounds relating to safety, quality or efficacy,  except after consultation with the appropriate 
committee. 
Provisional opinion against tradi tional 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— 
(a) may be unable to advise the licensing authority  to grant or renew the traditional herbal 
registration; or 
(b) may be unable to advise the licensing authority  to grant it unless it contains provisions 
otherwise than in accordance with the application; or 
(c) may have to advise the licensing authority th at the traditional herbal  registration ought to 
be revoked, varied or suspended,  
 13the 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 hol der 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 (2), or within such shorter peri od 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— 
(a) take into account such representations as are made in accordance with this paragraph; and 
(b) report their findings and advice to the li censing authority, together with the reasons for 
their advice. 
Licensing authority’s deci sion after appropriate committee report 
10.—(1) After receiving the report of the appropriate committee pursuant to paragraph 9(8) the 
licensing authority shall— 
(a) decide whether to refuse to grant or renew the traditional herbal regist ration, or to grant or 
renew it otherwise than in accordance with the application, or to proceed further with their proposal to revoke, vary or suspend the traditional herbal registration; and 
(b) take the report into account when making their decision. 
(2) The licensing authority shall then notify the applicant or holder 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. 
Licensing authority proposals in other cases 
11.—(1) If— 
(a) the appropriate committee was consulted pursuant to paragraph 8; 
(b) the committee did not give a prov isional opinion under paragraph 9(1); and 
(c) the licensing authority propose— 
(i) to determine the application in a way which differs from the advice of the committee, 
(ii) to revoke, vary or suspend a traditional herbal registration against such advice, or 
(iii) on grounds not relating to safety, quality or efficacy—  
 14(aa) not to grant or renew a tr aditional herbal registration, 
(bb) to grant or renew a traditional herbal registration otherwise than in accordance 
with an application, or 
(cc) to revoke, vary or suspend a traditional herbal registration, 
the licensing authority shall notify the applicant or holder accordingly. 
(2) If— 
(a) the appropriate committee has not been consulted pursuant to paragraph 8; and 
(b) the licensing authority propose, on grounds not rela ting to safety, quality or efficacy— 
(i) not to grant or renew a tr aditional herbal registration, 
(ii) to grant or renew a traditional herbal registration otherwise than in accordance with 
an application, or 
(iii) to revoke, vary or suspend a traditional herbal registration, 
the licensing authority shall notify the applicant or holder accordingly. 
(3) A notification given under sub-paragraph (1) or (2) shall state— 
(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 wh om 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 th e 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 licensi ng 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 suspensi on 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 aut hority 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 im mediate effect by virtue of 
paragraph 13—  
 15(a) it appears to the licensing authority; or 
(b) the appropriate committee advise, 
that the traditional herbal re gistration 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). 
PART 3 
VARIATION OF TRADITIONAL HERBAL REGISTRATION ON APPLICATION 
OF HOLDER 
Hearing before appropriate committee 
15.—(1) If the licensing authority decide, on groun ds relating to safety, quality or efficacy— 
(a) to refuse to grant a complex variation applicati on or a new excipient v ariation 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 li censing 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  
 16(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 aut hority 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 th e licensing authority that he wishes to appear 
before and be heard by a person appointed by the licensi ng 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. 
PART 4 
REFERRAL TO THE COMMITTEE FOR HERBAL MEDICINAL PRODUCTS IN 
ACCORDANCE WITH ARTICLE 16C(4) OF THE 2001 DIRECTIVE 
Hearing before appropriate committee 
18.—(1) If the licensing authority propose to refer an application for a traditional herbal 
registration to the Committee for Herbal Medicinal Products in accordance with Article 16c(4) of 
the 2001 Directive 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  
 17sub-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 li censing 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 aut hority 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 allo wed, notify the licensing authority that he wishes 
to appear before and be heard by a person appointed by th e 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. 
PART 5 
HEARING BEFORE PERSON APPOINTED 
Hearing before person appointed 
21.—(1) If an applicant or holder of a traditional  herbal registration 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, the authority shall— 
(a) make that appointment; and 
(b) arrange for the applicant or holder to hav e 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—  
 18(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 beginni ng with the date of the notice referred to in 
sub-paragraph (1). 
(4) If the applicant or holder so requests, the pe rson 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 dat e 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 Co mmittee for Herbal Medicinal Products, 
(iii) to grant or renew the trad itional 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 tr aditional 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 Co mmittee for Herbal Medicinal Products, 
(iii) to grant or renew the trad itional 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 tr aditional 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.  
 19 SCHEDULE 3 Regulation 9(6) 
OFFENCES, PENALTIES ETC 
Offences 
1. Any person who, in breach of these Regulations, places a traditional herbal medicinal product 
on the market without holding a traditional herbal registration in respect of that product, or otherwise than in accordance with the terms of such a registration, shall be guilty of an offence. 
2. Any person who, in the course of a business carried on by him, sells, supplies, manufactures 
or assembles, or procures the sale, supply, ma nufacture or assembly of, a traditional herbal 
medicinal product, or who has in his possession a traditional herbal medicinal product, knowing or 
having reasonable cause to believe that the product was or is intended to be placed on the market 
contrary to paragraph 1 shall be guilty of an offence. 
3. Without prejudice to any other sanction wh ich may be available for the enforcement of 
conditions attaching to traditi onal herbal registrations, any holder of a traditional herbal 
registration for a traditional herbal medicinal product who contravenes any condition of the 
registration shall be guilty of an offence. 
4. Any person who is the holder of a traditional herbal registration w ho fails to implement an 
urgent safety restriction imposed on him by  the licensing authority under regulation 8  shall be 
guilty of an offence. 
5. Where the use, supply or marketing of a traditional herbal medicinal product is suspended in 
accordance with regulation 7, any person who sells, supplies or markets, or procures the sale, 
supply or marketing of, that product knowing, or ha ving reasonable cause to believe, that such use, 
supply or marketing is suspended, shall be guilty of an offence. 
6. Any person who is or, immediately before its revocation or suspension, was the holder of a 
traditional herbal registration who fails to comply  with a notice given to him under regulation 7(5) 
(notice to take all reasonably practicable steps to  publish information concerning revocation or 
suspension or to recover possession of products affected) shall be guilty of an offence. 
7. Any holder of a traditional herbal regi stration who fails promptly to— 
(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 authori ty as required by the third or fourth 
paragraphs of Article 23 of the 2001 Directive; or 
(d) submit any application to the licensing aut hority to make any changes or variation as 
required by that Article; or 
(e) notify the licensing authority if the traditi onal 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 th e final paragraph of Article 23 of the Directive— 
(a) where the licensing authority have served a wr itten notice on the holder under regulation 
9(7) in relation to the request, with in the time specified in that notice; 
(b) where there is no such notice, promptly,  
 20shall 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 authori ty pursuant to regulation 9(5)— 
(a) where the licensing authority have served a wr itten notice on the holder under regulation 
9(7) in relation to the request, with in 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 traditi onal 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 w ho communicates to the general public 
information relating to pharmacovigilance concerns ab out the product to which the registration 
relates without having previ ously 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 th at information relating to 
pharmacovigilance concerns about the product to which the registration relates which he 
communicates to the general public or the licensi ng 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 author ity 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 su spected 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 coll ecting 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 aut hority for the provision of additional 
information necessary for the evaluation of th e benefits and risks afforded by a traditional 
herbal medicinal product is answered fully and promptly; or 
(d) provide to the licensing authority any other infor mation 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  
 21(b) provides to the licensing authority any info rmation which is relevant to an evaluation of 
the safety, quality or efficacy of the traditi onal 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 regi stration holder for a traditional  herbal medicinal product; or 
(c) while employed or engaged as an ap propriately 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 inform ation 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 leafl et 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 traditi onal herbal medici nal 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 label ling 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 in spection 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 inform ation 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;  
 22(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 prov isions relating to the regist ration 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 diligen ce 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. 
 SCHEDULE 4 Regulation 11(2)(a) 
MODIFICATIONS OF ENFORCEMENT PROVISIONS OF THE ACT 
1. In section 107 (validity of deci sions and proceedings relating thereto)— 
(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 “th is 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 provisi ons 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 provis ions 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—  
 23“(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 “contrav ention” 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 th is 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, ta ke samples and seize goods and documents)— 
(a) in subsection (1), for the word s 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 writi ng 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).  
 248. In section 116 (liability to forfeiture under Customs and Excise Management Act 1979)— 
(a) for “this Act”, in both places those wo rds 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 Pub lic Safety, acting jointly.”. 
9. In section 118 (restrictions on disclosure of in formation), 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 ap plies 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);  
 25(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 legi slation” 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 functi ons” onwards substitute “(in this 
Schedule referred to as “the relevant enforcement authority”) of their functions under 
those Regulations or under any provision of this Ac t 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,”. 
 SCHEDULE 5 Regulation 12 
LABELS 
Interpretation 
1. In this Schedule— 
“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 par ticular 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 herb al 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—  
 26(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 sup plies 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 me dicinal product or its common name, 
(ii) directions for use of the traditi onal herbal medi cinal product, and 
(iii) precautions relating to the use of the traditional herbal medicinal product, 
or where a pharmacist, in the exercise of his professi onal skill and judgement, is of the 
opinion that any of such particulars are inappropri ate 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 th e 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 pr oducts not on a general sale list 
4. Subject to the following provisions of this  Schedule, where a traditi onal 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 sal e by retail, every container and every 
package immediately enclosing a container of such a product shall unless the product is a 
dispensed traditional herbal m edicinal product, be labell ed 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 medici nal 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 th e 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  
 27(ii) in the form of a wrapper consisting of paper, film, plastic material, metal foil or other 
sheet or strip material or in the for m of a bubble, blister or other sealed unit 
consisting of such sheet or strip materi al, enclosing one or more dosage units of a 
traditional herbal medicinal  product and such container is im mediately 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. 
 SCHEDULE 6 Regulation 12 
TRANSITIONAL PROVISION 
1. The provisions of these Regulations shall not appl y until 30th April 2011 to herbal medicinal 
products which were on the market in the United Kingdom on 30th April 2004 without a 
marketing authorization by virt ue of section 12(2) of the Act. 
 SCHEDULE 7 Regulation 12 
CONSEQUENTIAL AMENDMENTS TO ORDERS AND 
REGULATIONS 
1. In the Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977( a), after article 1 
insert the following article— 
“Application 
1A. Nothing in this Order applies to a medicinal product for human use to which the 
Medicines (Traditional Herbal  Medicinal Products for Hu man Use) Regulations 2005 
apply.”. 
2. In the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980( b), in  
regulation 5 (restrictions on persons to be supplied with certain medici nal products), in paragraph 
(1)(a), after “Marketing Authorizations Etc.) Re gulations 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( c) is amended as 
follows. 
(2) In article 1 (citation, commencement and interpretation), in paragraph (2), after the definition 
of “supply” insert the following definition— 
                                                                                                                                                               
 
(a) S.I. 1977/2130. 
(b) S.I. 1980/1923, paragraph (1) of regulation 5 was amended by S.I. 1994/3142 and 3144. 
(c) S.I. 1980/1924; relevant amending instruments are S.I. 2000/1919 and 2003/697.   
 28““traditional herbal registration”  means a registration granted by the licensing authority 
under The Medicines (Traditional Herbal Medicinal Products for Human Use) 
Regulations 2005;”. 
(3) In article 4A (exemption for the supply of me dicinal products by na tional health service 
bodies)( a), in paragraph (2)(e), after “marketing authori zation” insert “, a traditional herbal 
registration”. 
(4) In article 4B (exemption for health professi onals who supply medicinal products under a 
Patient Group Direction in order to assist docto rs or dentists in providing national health 
services)( b), 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)( c), in paragraph (2)(e), after “marketing authori zation” insert “, a traditional 
herbal registration”. 
(6) In article 4D (exemption for health professionals who supply me dicinal products under a 
Patient Group Direction in order to assist the pro vision of health care by or on behalf of the police, 
the prison services or the armed forces)( d), in paragraph (2)(f), after “marketing authorization” 
insert “, a traditional  herbal registration”. 
4.—(1) The Medicines (Products Other Than Vete rinary Drugs) (General Sale List) Order 
1984( e) is amended as follows. 
(2) In article 1 (citation, commencement and interpretation), in paragraph (2)(a)— 
(a) in the definition of “marketing authorization”( f), after “Evaluation of Medicinal 
Products” insert “or by the European Medi cines Agency under Regulation (EC) No. 
726/2004 of the European Parliament and of the Council laying down Community 
procedures for the authorisation and supervisi on of medicinal products for human and 
veterinary use and establishing a European Medicines Agency( g)”; and 
(b) after the definition of “product licence of right” insert the following definition— 
““traditional herbal registration”  means a registration granted by the licensing authority 
under the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005; and”. 
(3) In article 2 (general sale list)— 
(a) after paragraph (a) insert the following paragraph— 
“(aa) medicinal products in respect of which a traditional herbal registration has been 
granted, which in the traditional herbal  registration are cl assified as being general 
sale list medicines;”; and 
(b) in paragraph (b) after “marketing authorization” in sert “or traditional  herbal registration”. 
5. In the Dangerous Substances and Prepara tions (Safety) (Consolidation) Regulations 1994( h), 
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— 
 “(ia) in respect of which there is for th e time being a traditional herbal registration 
granted under regulation 6 of the Medicines (Traditional Herbal Medicinal 
Products for Human Use) Regulations 2005, or”. 
6. In the Medicines (Aristolochia and Mu Tong etc.) (Prohibition) Order 2001( a), in article 4 
(Exceptions to the prohibitions imposed by articles 2 and 3), in paragraph (4), after “(Marketing 
                                                                                                                                                               
 
(a) Article 4A was inserted by article 2(c) of S.I. 2000/1919. 
(b) Article 4B was inserted by article 2(c) of S.I. 2000/1919. 
(c) Article 4C was inserted by article 3 of S.I. 2003/697. 
(d) Article 4D was inserted by article 3 of S.I. 2003/697. 
(e) S.I. 1984/769; relevant amending instrument is S.I. 2002/933. 
(f) The definition of “marketing authorization” was inserted by article 2(a) of S.I. 2002/933. 
(g) OJ No. L136, 30.4.2004, p.1. 
(h) S.I. 1994/2844, regulation 1(2) was amended by S.I. 1996/2635 and 2004/1031.  
 29Authorisations Etc.) Regulations 1994” insert “, a traditional herbal registration within the 
meaning of regulation 2(1) of the Medicines (T raditional Herbal Medicinal Products for Human 
Use) Regulations 2005”. 
7. In the Medicines for Human Use (Kava-Kava) (Prohibition) Order 2002( b), in article 3 
(Exceptions to the prohibition imposed by article 2), in paragraph (d)— 
(a) at the end of sub-paragraph (iii) insert “, or”; and 
(b) after sub-paragraph (iii) insert the following sub-paragraph— 
 “(iv) a traditional herbal registration within  the meaning given in regulation 2(1) of 
the Medicines (Traditional Herbal Medi cinal Products for Human Use) 
Regulations 2005.”. 
8. In the Unlicensed Medicinal Products for Human Use (Transmissible Spongiform 
Encephalopathies) (Safety)  Regulations 2003( c), in regulation 1 (citation, commencement and 
interpretation), in paragraph (2)— 
(a) in the definition of “unlicensed product”— 
(i) in sub-paragraph (a)(ii) after “Medicinal Pr oducts” insert “or under Regulation (EC) 
No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and  supervision of medicinal products 
for human and veterinary use and estab lishing a European Medicines Agency”, 
(ii) at the end of sub-paragraph (b) insert “or”, and 
(iii) after sub-paragraph (b) insert the following sub-paragraph— 
“(c) no traditional herbal regist ration has been granted by th e licensing authority under 
the Medicines (Traditional Herbal Medi cinal Products for Human Use) 
Regulations 2005;”; and 
(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 medi cinal products for human use”. 
 
EXPLANATORY NOTE 
(This note is not part  of the Regulations) 
These Regulations implement Directive 2004/24/ EC of the European Parliament and of the 
Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC( d) on 
the Community code relating to  medicinal products for human use( e) (the “2001 Directive”). 
Directive 2004/24/EC amended the 2001 Directive to introduce a simplified registration 
procedure for the marketing of traditional herbal medicinal products for human use.  These 
Regulations introduce a scheme of traditional herbal registrations (defin ed in Regulation 2). 
Regulation 3 provides that th e licensing authority established under section 6 of the Medicines 
Act 1968 (consisting of the Secretary of Stat e for Health, the Secretary of State for Environment 
and Rural Affairs, and the Northern Ireland Departme nt for Health, Social Services and Public 
Safety and the Northern Ireland Department for Agriculture and Rural Development) will perform 
the functions of the competent authority in relati on to the provisions of the 2001 Directive which 
apply to traditional herbal  medicinal products. 
Regulation 4(1) requires all traditional herbal medicinal products placed on the market or 
distributed by wholesale dea ling to be registered in accordance with these Regulations. 
                                                                                                                                                               
(a) S.I. 2001/1841. 
(b) S.I. 2002/3170. 
(c) S.I. 2003/1680, regulation 1(2) was amended by S.I. 2004/3224. 
(d) 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. 
(e) OJ No. L136, 30.4.2004, p.85.  
 30Regulation 4(2) and Schedule 1 set out exemptions under which traditional herbal medicinal 
products may be supplied or administered without a traditional herbal registration provided the 
conditions set out in Schedule 1 are complied with. In particular, doctors, dentists and 
supplementary prescribers may prepare, or order to be prepared, traditional herbal medicinal 
products to be used by their individual patients. 
Regulations 5 to 7 and Schedule 2 make provisi on for applications for the grant, renewal and 
variation of traditional herbal  registrations, and for the licensing authority to revoke, vary or 
suspend traditional herbal registrations.  In par ticular, Schedule 2 makes provision for reference to 
the appropriate committee of decisions to refuse traditional herbal registrations, proposals to refer 
applications in certain circumstances to the Committee for Herbal Medicinal Products, and to 
revoke, vary or suspend a registration. 
Regulation 8 makes provision for the licensing aut hority to impose an urgent safety restriction 
on the holder of a traditi onal herbal registration. 
Regulation 9 imposes obligations on the ho lders of traditional herbal registrations. 
Regulations 9(6) and 11 and Schedules 3 and 4, make provision for enforcement and related 
matters, including powers of inspection, offences and penalties for breaches of the Regulations. 
Regulation 12 and Schedule 5 impose labelling require ments for traditional  herbal medicinal 
products which are prepared or dispensed in accordance with a prescription, or available only from 
a pharmacy. 
Regulations 10 and 12 and Schedules 6 and 7, contain miscellaneous provisions for the 
consequential amendment of legisla tion and for transitional arrangements. 
A Regulatory Impact Assessment in relation to these Regulations, and a Transposition Note in 
relation to the implementation of Directive 2004/24/EC, have been placed in the libraries of both 
Houses of Parliament and copies may be obt ained from the Medicines and Healthcare products 
Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.   
 
 
¤ Crown copyright 2005 
Printed and published in the UK by The Stationery Office Limited 
under the authority and superintendence of Carol Tullo, Controller of Her Majesty’s Stationery Office and Queen’s Printer of Acts of Parliament. 
E1403  10/2005 151403T  19585 S.I. 2005 No. 2750 The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005