STATUTORY INSTRUMENTS 
2005 No. 2759 
MEDICINES 
The Medicines (Marketing Authorisations Etc.) Amendment 
Regulations 2005 
Made - - - - 6th October 2005 
Laid before Parliament 7th October 2005 
Coming into force 
for the purpose of regulation 2(2)(a)(ii) and (vi) and (c),(9)(a),(11)(a),(14)(e),(f)(i),(iii) to (v) and 
 paragraphs 3 to 5, 6(b)(iii), 7 to  9, 11, 12 
and 17(b) of the Schedule 20th November 2005 For all other purposes 30th October 2005 
The Secretary of State, being 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 and commencement 
1. These Regulations may be cited as the Medici nes (Marketing Authorisations Etc.) Amendment 
Regulations 2005 and shall come into force— 
(a) except for the purposes of the provisions speci fied in paragraph (b), on 30th October; and 
(b) for the purposes of paragraphs (2)(a)(ii) and (vi) and (c), (9)(a), (11)(a) and (14)(e), (f)(i), (iii) to (v) 
of regulation 2, and paragraphs 3 to 5, 6(b)(iii), 7 to 9, 11, 12 and 17(b) of the Schedule, on 20th November 2005. 
Amendment of the Medicines for Human Use (Mark eting Authorisations Etc.) Regulations 1994 
2.—(1) The Medicines for Human Use (Marketi ng Authorisations Etc.) Regulations 1994( c) are amended 
as follows. 
(2)  In regulation 1 (citation, commencement and interpretation)— 
(a) in paragraph (2)— 
(i) after the definition of “the Act”  insert the following definition— 
““certificate of registration” means a certificate of registration granted by the licensing authority 
under the Medicines (Homoeopathi c Medicinal Products for Human Use) Regulations 1994( a);”, 
                                                                                                                                                                              
 
 
(a) S.I. 1972/1811. 
(b) 1972 c.68. 
(c) S.I. 1994/3144; relevant amending instruments are S.I 2001/795, 2002/236, 2003/2321, 2004/3224, 2005/50 and 2005/1710.  2(ii) in the definition of “Community marketi ng authorization”, after “2309/93” insert “or 
Regulation (EC) No. 726/2004( b)”, 
(iii)  in the definition of “the 2001 Directive”— 
(aa) after “as amended by Commission Direc tive 2003/63/EC” insert “, Directive 
2004/24/EC”( c), and 
(bb) omit “Article 1(21), (44), (45) and (54) of ”, 
(iv) after the definition of “the 2001 Direc tive” insert the following definition— 
““Directive 2004/24/EC” means Directive 2004/24/ EC of the European Parliament and of the 
Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the 
Community code relating to medicinal products for human use( d);”, 
(v) for the definition of “EEA State” substitute the following definition— 
““EEA State” means a Member State, Norway, Iceland or Liechtenstein;” 
(vi) in the definition of “the rel evant Community provisions”— 
(aa) omit “Regulation (EEC) No. 2309/93;”, and 
(bb) omit “Title IV of”, 
(vii) for the definition of “relevant medicinal product” substitute the following definition— 
““relevant medicinal product” means, except in regulation 3A and paragraph 1A of Schedule 3, a 
medicinal product for human use to which the prov isions of the 2001 Directive apply other than— 
(a) a traditional herbal medicinal product, or 
(b) a homoeopathic medicinal product that fulfils the conditions laid down in Article 14(1) of the 
2001 Directive;”, and 
(viii) after the definition of “supplementary prescriber” insert the following definition— 
““traditional herbal registrat ion” means a traditional herbal regist ration granted by the licensing 
authority under the Medicines (Traditional Herbal Medicinal Products for Human Use) 
Regulations 2005( e);”; 
(b) omit paragraph (3); and 
(c) omit paragraph (5A). 
(3)  In regulation 3 (marketing authorizations for rel evant medicinal products) in paragraph (1) for 
“paragraphs 1 and 3” substitute “paragraphs 1 and 3 to 5A”. 
(4)  In regulation 3A (borderline products)( f)— 
(a) in paragraph (1), after “marketing aut horization” insert “, traditional herbal registration or certificate 
of registration”; 
(b) in paragraph (6), after “marketing aut horization” insert “, traditional herbal registration or certificate 
of registration”; and 
(c) after paragraph (7) insert the following paragraph— 
“(8) In this regulation, “relevant medicinal product” means a medicinal product for human use to 
which the provisions of the 2001 Directive apply.”. 
(5)  After regulation 3A (borderline products) insert the following regulation— 
                                                                                                                                                                               
(a) S.I. 1994/105; as amended by S.I. 1994/899, 1995/541, 1996/482, 1998/574, 1999/566, 2001/795, 2002/236 and 542, 2003/625 and 2321, 
2004/666 and 2005/2753 
(b) OJ  No. L136, 30.4.2004, p.1. 
(c) OJ No. L159, 27.6.2003, p.46. 
(d) OJ No. L136, 30.4.2004, p.85. 
(e) S.I. 2005/2750 
(f) Regulation 3A was inserted by regulation 3 of S.I. 2000/292.  3“Immunity from liability for consequences arising from the use in certain cases of an 
unauthorised medicinal product or the use of a medicinal product for an unauthorised 
indication 
3B.—(1) This regulation applies where, in response to the suspected or confirmed spread of 
pathogenic agents, toxins, chemi cal agents or nuclear radiation whic h may cause harm to humans, the 
licensing authority recomme nd or require the use of— 
(a) a medicinal product which is  not the subject of a Communi ty marketing authorization or a 
United Kingdom marketing authorization; or 
(b) a medicinal product which is the subject of such an authorization, for a therapeutic indication 
which is not included in the summary of product characteristics under that authorization. 
(2) Subject to paragraph (3)— 
(a) the holder of a marketing authorization for th e product the use of which is recommended or 
required by the licensing authority; 
(b) a manufacturer of that product; (c) an officer, servant, employee or agent of a person referred to in sub-paragraph (a) or (b); and (d) a health professional, 
shall not be subject to any civil liability for any loss or damage resulting from the use of the product 
in accordance with the recommendation or requirement. 
(3)  Paragraph (2) shall not apply in relation to liab ility under section 2 of the Consumer Protection 
Act 1987( a). 
(4) In this regulation, “health professional” means— 
(a) a doctor, (b) a dentist, (c) a registered nurse ( b), 
(d) a pharmacist, 
(e) a person registered in a register of optometrist s maintained under section 7 of the Opticians 
Act 1989( c), 
(f) a person registered in a register established and maintained under article 5 of the Health 
Professions Order 2001( d), 
(g) a registered osteopath as defined by sec tion 41 of the Osteopaths Act 1993( e), or 
(e) a registered chiropractor as defined by section 43 of the Chiropractors Act 1994( f).”. 
(6)  In regulation 4 (applications for the grant, renewal  or variation of a United Kingdom marketing 
authorization)— 
(a) for paragraphs (3) and (4), substitute the following paragraph— 
“(3) One copy of the application and of any accompanying material shall be supplied to the 
licensing authority in the English language and where the application or any accompanying material has been translated from another language, one copy of the application or the accompanying material, 
as the case may be, shall also be suppli ed in the original language.”; 
(b) for paragraph (6), substitute the following paragraph— 
“(6) For the purposes of Article 10(1) of the 2001 Directive, the period of 8 years (period during 
which reference medicinal products must have been auth orized) there mentioned shall not apply if the 
                                                                                                                                                                              
 
 
(a) 1987 c.43. 
(b)  See the definition of “registered”, in relation to nurses and midwives, in Schedule 1 to the Interpretation Act 1978, as substitute d by S.I. 
2002/53 and amended by S.I. 2004/1771. 
(c) 1989 c. 44. 
(d) S.I. 2002/254. 
(e) 1993 c. 21. 
(f) 1994 c. 17.  4application for the authorization of the reference medicinal product was submitted before 30th 
October 2005.”; 
(c) after paragraph (6), insert the following paragraphs— 
“(6A) Where, by reason of paragraph (6) the period of 8 years does not apply, the applicant shall 
not be required to provide the results of pre–clinical te sts and of clinical trials if he can demonstrate 
that the medicinal product is a generic of a reference medicinal product whic h has been authorized in 
an EEA State for not less than 10 years. 
(6B) The fourth sub-paragraph of Article 10(1) of the 2001 Directive shall not apply if the 
application for the initial authorization of the reference medicinal product was submitted before 30th October 2005.”; and 
(d) in paragraph (9), for “3” substitute “6”. 
(7)  In regulation 5 (consideration, an d grant or refusal, of an applicati on for, or renewal or variation of, a 
United Kingdom marketing authorization)— 
(a) for paragraph (4) substitute the following— 
“(4) 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 4(9) it shall 
remain in force pending the decision of the licensi ng authority on that  application.”; and 
(b) after paragraph (4), insert the following paragraphs— 
“(5) An authorization granted by the licensing authority in accordance with Article 126a of the 2001 
Directive shall, unless previously revoked, be valid for the period specified in it. 
(6) Subject to paragraph (8), a United Kingdom ma rketing authorization, other than a parallel 
import licence shall, unless previously rev oked, be valid for an unlimited period unless— 
(a) it has not been renewed on the basis of a re-ev aluation 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 authority  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. 
(7) Subject to paragraph (8), where, by reason of paragraph (6), a United Kingdom marketing 
authorization is not valid for an unlimited peri od, 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 marketing authorization shall remai n in force pending the decision of the licensing 
authority on that application. 
(8) Subject to paragraph (9), a United Kingdom ma rketing authorization (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. 
(9) For the purposes of calculating the period of three consecutive years referred to in paragraph (8), 
no account shall be taken of any period before 30th October 2005.”. 
(8)  In regulation 5A (classification of medici nal products), after paragraph (1) insert the following 
paragraph— 
“(1A) For the purposes of paragraph (1), “marketing authorization” includes an authorization 
granted by the licensing authority in accordance with Article 126a of the 2001 Directive.”. 
(9)  In regulation 6 (revocation, suspension or variati on of a United Kingdom marketing authorization or 
the suspension of the use or marketing of medicinal products)— 
(a) in paragraph (5), for “Council Regulation (EEC) No. 2309/93” substitute “Regulation (EC) No. 
726/2004”; and 
(b) after paragraph (7), insert the following paragraph—  5“(7A) For the purposes of this regulation, “marke ting authorization” incl udes an authorization 
granted by the licensing authority in accordance with Article 126a of the 2001 Directive.”. 
(10)  In regulation 6A (urgent safety restrictions)— 
(a) in paragraph (1), after “marketing authori zation” insert “or an authoriza tion granted by the licensing 
authority in accordance with Article 126a of the 2001 Directive”; and 
(b) in paragraph (2), omit “marketing”. 
(11)  In regulation 7 (obligations of holders of ma rketing authorizations, and offences by holders of 
marketing authorizations and other persons)— 
(a) in paragraph (1), for “Regulation (EEC) No. 2309/93” substitute “Regulation (EC) No. 726/2004”; 
(b) after paragraph (3), insert the following paragraph— 
“(3A) Where a person is authorised by the licensing authority to place a product on the market in 
accordance with Article 126a of the 2001 Directive, he shall comply with all obligations under Titles V, VI, VIII, IX and XI of that Directive which would apply to him by virtue of those provisions and 
these Regulations if he were the holder of a Unit ed Kingdom marketing authori zation for that product.
”; and 
(c) after paragraph (6), insert the following paragraph— 
“(7) For the purposes of paragraphs (2), (3), (4) and (6), “marketing authorization” includes an 
authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive.
”. 
(12)  In regulation 9 (consequential and other amendments of the Act and the Medicines Act 1971), after 
paragraph (14), insert the following paragraphs— 
“(15) Subject to paragraph (16), for the purposes of th is regulation, “marketi ng authorization” 
includes an authorization granted by the licensing authority in accordance with Article 126a of the 2001 Directive. 
(16) Paragraph (15) shall not apply in relation to paragraph (10).”. 
(13)  In Schedule 1 (exemptions and excepti ons from the provisions of regulation 3)— 
(a) in paragraph 1, after “responsibility” insert “, in orde r to fulfil the special needs of those patients”; 
(b) in paragraph 2, for sub-paragraph (e) substitute the following sub-paragraph— 
“(e) if the relevant medicinal product is ma nufactured 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, assem bly or import of relevant medicinal 
products to which paragraph 1 applies; or 
 (ii) has been manufactured, assembled or imported  as an investigational medicinal product 
by the holder of a manufacturing authorization granted by the licensing authority for the 
purposes of regulation 36 of the Medicines for Human Use (Clinical Trials) Regulations 
2004( a); and”; and 
(c) after paragraph 5 insert the following paragraph— 
“5A. Regulation 3(1) shall not apply to a medi cinal product for which there is in force an 
authorization to place the product on the market granted by the licensing authority in accordance with 
Article 126a of the 2001 Directive.”. 
(14)  In Schedule 3 (offences, penalties etc)— 
(a) paragraph 1A( b) is amended as follows— 
(i) paragraph 1A shall be renumbered as sub-paragraph (1) of that paragraph, 
(ii) in paragraph (a) of sub-paragraph (1), after “marketing authorization”, in both places those 
words appear, insert “, traditional herbal regist ration or certificate of registration”, 
                                                                                                                                                                               
 
(a) S.I. 2004/1031. 
(b) Paragraph 1A was inserted by regulation 4(1) of S.I. 2000/292.  6(iii) in paragraph (b) of sub-paragraph (1), after “marketing authorization”, in both places those 
words appear, insert “, traditional herbal registration or certif icate of registration”, and 
(iv) after sub-paragraph (1), insert the following sub-paragraph— 
“(2) In this paragraph, “relevant medicinal product ” means a medicinal product for human use to 
which the provisions of the 2001 Directive apply.”. 
(b) after paragraph 1A insert the following paragraph— 
“1AA.  Any person who places a generic medicinal product on the market before the period of — 
(a) in a case where during the first eight years after the grant of the initial marketing 
authorization of the reference medici nal product the holder of that authorization is granted an 
authorization for a new therapeutic i ndication of significant clini cal benefit as set out in the 
fourth sub-paragraph 4 of Article 10(1) of the 2001 Directive, eleven years; and 
(b) in any other case, ten years 
has elapsed from the date of that initial authorization, shall be guilty of an offence.”; 
(c) in paragraph 2, after “paragraph 1” insert “or paragraph 1AA”; 
(d) after paragraph 2, insert the following paragraph— 
“2A. Any person who distributes a relevant medicinal  product by way of wholesale dealing contrary 
to regulation 3(1)(b) shall be guilty of an offence.”; 
(e) in paragraphs 4, 7, 8, 9 and 10 for “Council Regulation (EEC) No. 2309/93” substitute “Regulation 
(EC) No. 726/2004”; 
(f) in paragraph 6— 
(i)  in sub-paragraph (b), for “Article 15.1 of Council Regulation (EEC) No 2309/93” substitute 
“Article 16.1 of Regulation (EC) No. 726/2004”, 
(ii) in sub-paragraph (cc), after “Article 23” insert “or the first paragraph of Article 23a”, 
(iii) in sub-paragraph (d), for “Article 15.2 of Council Regulation (EEC) No 2309/93” substitute 
“Article 16.2 of Regulation (EC) No. 726/2004” and, after the semi-colon, omit “or”, 
(iv) after sub-paragraph (d), insert the following sub-paragraph— 
“(dd) provide information to the EMEA as required by the first or second paragraphs of 
Article 13(4) of Regulation No. 726/2004; or”, and 
(v) in sub-paragraph (e), for “Article 15.3 of Council Regulation (EEC) No 2309/93” substitute 
“Article 16.3 of Regulation (EC) No. 726/2004”; 
(g) in paragraph 6A, after “Article 23”, insert “or of Article 23a”; 
(h)  after paragraph 6A, insert the following paragraphs— 
“6B. Subject to paragraph 17, any person who is the holder of a United Kingdom marketing 
authorization who fails, not less than two months before an interruption in the placing on the market 
of the product to which the authoriza tion relates, to notify the licensing authority that the product is to 
cease to be placed on the market, shall be guilty of an offence. 
6C. Subject to paragraph 17, any person who is the holder of a Community or United Kingdom 
marketing authorization who fails to ensure appropriat e and continued supplies pursuant to the second 
paragraph of Article 81 of the 2001 Directive shall be guilty of an offence. 
6D. Any person who is the holder of a Community marketing authorization who fails to provide the 
EMEA with any data requested pursuant to the fi nal paragraph of Article 13(4) or the final paragraph 
of Article 26 of Regulation (EC) No. 726/2004— 
(a) within the time specified in the request, if a time within which to provide the data to the 
EMEA is so specified; or 
(b) promptly, if no such time is specified, 
shall be guilty of an offence.  76E. Any person who is the holder of a Community or United Kingdom marketing authorization who 
communicates to the general public information— 
(a) relating to pharmacovigilance concerns about the product  to which the authorization relates; 
(b) without having previously communicated, or without si multaneously communicating, such 
information to the EMEA, in the case of a product  for which there is a Community marketing 
authorization, or otherwise the licensing authority,  
shall be guilty of an offence. 
6F. Any person— 
(a) who is the holder of a Community or United Kingdom marketing authorization; and 
(b) who fails to ensure that the information wh ich he communicates to the general public, the 
licensing authority or the EMEA relating to  pharmacovigilance concerns about the product to 
which his authorization rel ates is presented objectively and is not misleading, 
shall be guilty of an offence.”; 
(i) in paragraph 17, after “paragraph” insert “6B, 6C,”; and 
(j) after paragraph 17, insert the following paragraphs— 
“Definitions 
18. For the purposes of paragraphs 1, 3, 3A, 4, 5, 6E, 6F, 11, 12 and 16, “marketing authorization” 
includes an authorization granted by the licensing authority in accordance with Article 126a of the 
2001 Directive. 
19. For the purposes of paragraphs 7, 8 , 9 and 10 the Directive requirements referred to in those 
paragraphs are deemed to apply in relation to the hol der of an authorization grant ed by the licensing 
authority in accordance with Article 126a of the 2001 Directive as they apply to the holder of a 
marketing authorization.”. 
(15)  In Schedule 6 (transitional provisions), aft er paragraph 4A insert the following paragraph— 
“4B. Until  30th October 2010, these Regulations shall appl y, in so far as they relate to the labelling 
of medicinal products in respect of which a marke ting authorization was granted before 30th October 
2005, as if the 2001 Directive had not been amended by Article 1(40), (41) and (42) of Directive 
2004/27/EC.”. 
Amendments of the Patents Act 1977 
3. In section 60 of the Patents Act 1977( a) (meaning of infringement)— 
(a) in subsection (5), after paragraph (h), insert the following— 
 “(i) it consists of— 
(i) an act done in conducting a study, test or trial which is necessary for and is 
conducted with a view to the application of paragraphs 1 to 5 of article 13 of 
Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of Directive 2001/83/EC, 
or 
(ii)  any other act which is required for the purpose of the application of those 
paragraphs.”, and 
(b) in subsection (7), at the end insert the following— 
““Directive 2001/82/EC” means Directive 2001/82/ EC of the European Parliament and of the 
Council on the Community code relati ng to veterinary medicinal products( b) as amended by 
Directive 2004/28 of the European Parliament and of the Council( a); 
                                                                                                                                                                               
 
(a) 1977 c.37. 
(b) OJ No. L311, 28.11.2001, p.1.  8“Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the 
Council on the Community code relating to medicinal products for human use, as amended by 
Directive 2002/98/EC of the European Parliament and of the Council, by Commission Directive 
2003/63/EC and by Directives 2004/24/EC an d 2004/27/EC of the European Parliament and of 
the Council”. 
Consequential amendments to enactments 
4. The provisions of the enactments specified in  the Schedule shall be amended as there specified. 
 
    
Signed by authority of the Secret ary of State for Health 
  Warner  
 Minister of State 
6th October 2005 Department 
 
                                                                                                                                                                               
(a) OJ No. L136, 30.4.2004, p.58.  9 
 SCHEDULE Regulation 4 
AMENDMENTS TO OTHER ENACTMENTS 
1. In the Medicines (Pharmacy and General Sale Exemption) Order 1980( a) in article 1 (citation, 
commencement and interpretation), in paragraph (2)— 
(a) in the definition of “Community  marketing authorization” after “Regulation (EEC) No. 2309/93” 
insert “or 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 establishing a European Medicines Agency”, 
(a) after the definition of “cosmetic” insert the following definition— 
““Directive 2001/83/EC” means Directive 2001/83/ EC of the European Parliament and of the 
Council on the Community code relating to medicinal products for human use as amended by  
Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality 
and safety for the collection, testing, processing,  storage and distributi on of human blood and 
blood components( b), Commission Directive 2003/63/EC am ending Directive 2001/83/EC on the 
Community code relating to medicinal products for human use, Directive 2004/24/EC of the 
European Parliament and of the Council amending, as regards traditional herbal medicinal 
products, Directive 2001/83/EC on the Community code relating to medicinal products for human 
use and  Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”, and 
(b) in the definition of “United Kingdom marke ting authorization” after “Schedule 6 to those 
Regulations” insert “or an aut horization granted by the licensing authority in accordance with 
Article 126a of  Directive 2001/83/EC”. 
2. In the Medicines (Applications for Grant of Pr oduct Licences – Products for Human Use) Regulations 
1993( c), in regulation 1 (citation, commencement and interpretation), in paragraph 2, in the definition of “the 
2001 Directive”, after “as amended”, insert “by  Direct ive 2002/98/EC of the European Parliament and of 
the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directiv e 2003/63/EC amending Directive 
2001/83/EC on the Community code relating to medi cinal products for human use, Directive 2004/24/EC of 
the European Parliament and of the Council amending, as regards traditional herbal  medicinal products, 
Directive 2001/83/EC on the Community code relating to medicinal products for human use and  Directive 
2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”. 
3. In the Medical Devices (Consultati on Requirements) (Fees) Regulations 1995( d), in regulation 1 
(citation, commencement and interpretation), in paragraph (2), in the definition of “ authorised medicinal 
product”, after “Council Regulation (EEC) No 2309/ 93”, insert “or Regulation (EC) No. 726/2004 of the 
European Parliament and of the Council laying dow n Community procedures for the authorisation and 
supervision of medicinal products for human and vete rinary use and establishing a European Medicines 
Agency”. 
4. In the Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 
1996( e), in regulation 3 (exemptions from requirement to carry out risk assessments), in paragraph (2)(c), 
after “Council Regulation (EEC) No 2309/93”, insert  “or Regulation (EC) No. 726/2004 of the European 
                                                                                                                                                                              
 
 
(a) S.I. 1980/1924; relevant amending instrument is S.I. 2000/1919. 
(b) OJ No. L33, 8.2.2003, p.30. 
(c) S.I. 1993/2538; relevant amending instruments are S.I. 2002/236 and S.I. 2003/2321. 
(d) S.I. 1995/449. 
(e) S.I. 1996/1106.  10Parliament and of the Council laying down Comm unity procedures for the authorisation and supervision of 
medicinal products for human and ve terinary use and establishing a European Medicines Agency”. 
5. In the Prescription Only Medicines (Human Use) Order 1997( a), in article 1 (citation, commencement 
and interpretation), in paragraph (2)— 
(a) in the definition of “Communi ty marketing authorization”, after  “Council Regulation (EEC) No. 
2309/93”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and of the Council 
laying down Community procedures for the authorisa tion and supervision of medicinal products for 
human and veterinary use and establishi ng a European Medicines Agency”, and  
(b) in the definition of “United Kingdom marke ting authorization” after “Schedule 6 to those 
Regulations” insert “or an aut horization granted by the licensing authority in accordance with 
Article 126a of  Directive 2001/83/EC”; 
6. In the Health Service Medicines (Control  of Prices of Branded Medicines) Regulations 2000( b) in 
regulation 2 (interpret ation), in paragraph 1— 
(a) after the definition of “branded health service medicine” insert the following definition— 
““Directive 2001/83/EC” means Directive 2001/83/ EC of the European Parliament and of the 
Council on the Community code relating to medicinal products for human use as amended by  
Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality 
and safety for the collection, testing, processing,  storage and distributi on of human blood and 
blood components, Commission Directive 2003/63/ EC amending Directive 2001/83/EC on the 
Community code relating to medicinal products for human use, Directive 2004/24/EC of the 
European Parliament and of the Council amending, as regards traditional herbal medicinal 
products, Directive 2001/83/EC on the Community code relating to medicinal products for human 
use and  Directive 2004/27/EC of the European Parliament and of the Council amending Directive 
2001/83/EC on the Community code relati ng to medicinal products for human use”; 
(b) in the definition of “marketing authorisation”— 
(i) for sub-paragraph (a), substitute the following— 
“(a) by the competent authority of the United Kingdom in accordance with Directive 
2001/83/EC and includes an authorisation granted by the competent authority in accordance with Article 126a of Directive 2001/83; or”, and 
(ii) in sub-paragraph (b), after “Evaluation of Medicinal  Products” insert “or Regulation (EC) No. 
726/2004 of the European Parliament and the Council laying down Community procedures for 
the authorisation and supervision of medici nal products for human and veterinary use and 
establishing a European Medicines Agency”. 
7. In the Genetically Modified Orga nisms (Contained Use) Regulations 2000( c) in regulation 3 
(application), in paragraph (3) (a) (ii), after “Council Regula tion (EEC) No 2309/93”, insert “or Regulation 
(EC) No. 726/2004 of the European Parliament and the Council laying down Community procedures for the 
authorisation and supervision of me dicinal products for human and vete rinary use and establishing a 
European Medicines Agency”. 
8. In the Biocidal Products Regulations 2001( d) in regulation 3 (application), in paragraph (1)(b), after 
“Evaluation of Medicinal Pr oducts”, insert “or Regulation (EC) No. 726/2004 of the European Parliament 
and the Council laying down Community procedures for th e authorisation and superv ision of medicinal 
products for human and veterinary use and establishing a European Medicines Agency”. 
9.
 In the Genetically Modified Organism s (Deliberate Release) (Scotland) Regulations 2002( e) in 
regulation 15 (exempt activities), after “Regulation (EEC) 2309/93”, insert “or Regulation (EC) No. 
726/2004 of the European Parliament and the Council laying down Community procedures for the 
                                                                                                                                                                               
 
(a) S.I 1997/1830; relevant amending instrument is S.I.2000/1917. 
(b)  S.I. 2000/123; relevant amending instruments are S.I. 2002/236 and S.I. 2004/3224. 
(c) S.I 2000/2831. 
(d) S.I. 2001/880. 
(e) S.I. 2002/541.  11authorisation and supervision of me dicinal products for human and vete rinary use and establishing a 
European Medicines Agency”. 
10. In the Medical Devices Regulations 2002( a), in regulation 2 (interpret ation), in paragraph (1), in the 
definition of “Directive 2001/83”, after “human use” insert “as amended by Directive 2002/98/EC of the 
European Parliament and of the Council setting standards of quality and safety for the collection, testing, 
processing, storage and distribution of human bl ood and blood components, Commission Directive 
2003/63/EC amending Directive 2001/83/EC on the Comm unity code relating to medicinal products for 
human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal  products, Directive 2001/83/EC on the Comm unity code relating to medicinal 
products for human use and  Directive 2004/27/EC of the European Parliament and of the Council amending 
Directive 2001/83/EC on the Community code relating to medici nal products for human use”. 
11. In the Genetically Modified Organi sms (Deliberate Release) Regulations 2002( b), in regulation 15 
(exempt activities), in paragraph (e), after “Commission  Regulation EC No. 649/98”, insert “or Regulation 
(EC) No. 726/2004 of the European Parliament and the Council laying down Community procedures for the 
authorisation and supervision of me dicinal products for human and vete rinary use and establishing a 
European Medicines Agency”. 
12. In the Genetically Modified Organism s (Deliberate Release) (Wales) Regulations 2002 ( Rheoliadau 
Organeddau A Addaswyd Yn Enetig (Eu Gollwng Yn Fwriadol) (Cymru) 2000 ) (c) in regulation 16 (exempt 
activities) ( gweithgareddau esempt ),in paragraph (e), in the English text , after “Commission Regulation EC 
No. 649/98”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and the Council laying 
down Community procedures for the authorisation and supervision of medicinal products for human and 
veterinary use and establishing a European Medi cines Agency” and in the Welsh text, after “Reoliad y 
Comisiwn EC Rhif 649/98” insert “neu Reoliad (EC) Rhif 726/2004 Senedd Ewrop a’r Cyngor sy’n gosod 
gweithdrefnau’r Gymuned ar gyfer awdurdodi a goruchwylio  cynhyrchion meddygi niaethol at ddefnydd 
pobl ac anifeiliaid a sefydlu Asiantaeth Meddyginiaethau Ewrop”. 
13. In the Food Supplements (England) Regulations 2003( d), in regulation 3 (scope of regulations), in 
paragraph (2), after “human use”, insert “as amended by Directive 2002/98/EC of the European Parliament 
and of the Council setting standards of quality and safety for the collection, testing, processing, storage and 
distribution of human blood and blood components, Commission Directiv e 2003/63/EC amending Directive 
2001/83/EC on the Community code relating to medi cinal products for human use, Directive 2004/24/EC of 
the European Parliament and of the Council amending, as regards traditional herbal  medicinal products, 
Directive 2001/83/EC on the Community code relating to medicinal products for human use and  Directive 
2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the 
Community code relating to medicinal products for human use”. 
14. In the Food Supplements (Scotland) Regulations 2003( e) in regulation 3 (scope of regulations) in 
paragraph (2), after “human use”, insert “as amended by Directive 2002/98/EC of the European Parliament 
and of the Council setting standards of quality and safety for the collection, testing, processing, storage and 
distribution of human blood and blood components, Commission Directiv e 2003/63/EC amending Directive 
2001/83/EC on the Community code relating to medi cinal products for human use, Directive 2004/24/EC of 
the European Parliament and of the Council amending, as regards traditional herbal  medicinal products, 
Directive 2001/83/EC on the Community code relating to medicinal products for human use and  Directive 
2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the 
Community code relating to medicinal products for human use”. 
15. In English text of the F ood Supplements (Wales) Regulations 2003(
f)(Rheoliadau Ychwanegion Bwyd 
(Cymru) 2003 )(g), in regulation 3 (scope of regulations) in  paragraph (2), after “human use”, insert “as 
amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of 
                                                                                                                                                                               
 
(a) S.I. 2002/618. 
(b) S.I. 2002/2443. 
(c) S.I. 2002/3188. 
(d) S.I.2003/1387. 
(e) S.I.2003/278. 
(f) S.I. 2003/1719. 
(g) S.I. 2003/1719.  12quality and safety for the collection, testing, processing, storage and distribution of human blood and blood 
components, Commission Directive 2003/ 63/EC amending Directive 2001/83/EC on the Community code 
relating to medicinal products for human use, Directiv e 2004/24/EC of the European Parliament and of the 
Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the 
Community code relating to medi cinal products for human use and  Directive 2004/27/EC of the European 
Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal 
products for human use”. In the Welsh text of the Regul ations, in regulation 3 (scope of regulations) in 
paragraph (2), after “i bobl eu defnyddio”, insert “fel y’ i diwygiwyd gan Gyfarwyddeb 2002/98/EC Senedd 
Ewrop a’r Cyngor sy’n gosod safonau ansawdd a diogelwch ar gyfer casglu, profi, prosesu, storio a dosbarthu gwaed a chydrannau gwaed dynol , Cyfarwy ddeb y Comisiwn 2003/63/EC sy’n diwygio 
Cyfarwyddeb 2001/83/EC ar god y Gymuned yngl/g468n â ch ynhyrchion meddyginiaethol i bobl eu defnyddio, 
Cyfarwyddeb 2004/24/EC Senedd Ewrop a’r Cyngor sy’n diwygio, o ran cynhyr chion meddyginiaethol 
llysieuol traddodiadol, Gyfarwyddeb 2001/83/EC ar god y Gymuned yngl/g468n â chynhyrchion 
meddyginiaethol i bobl eu defnyddio a Chyfarwy ddeb 2004/27/EC Senedd Ewrop a’r Cyngor sy’n diwygio 
Cyfarwyddeb 2001/83/EC ar god y Gymuned yngl/g468n â chy nhyrchion meddyginiaethol i bobl eu defnyddio”. 
16. In the National Health Service (General  Medical Services Contract s) (Wales) Regulations 2004( a) in 
paragraph 43 of Schedule 6 (restric tions on prescribing by supplementar y prescribers), in sub-paragraph (6), 
after “human use”, insert “as amended by Directive 2002/98/EC of the European Parliament and of the 
Council setting standards of quality and safety for the col lection, testing, processing, storage and distribution 
of human blood and blood components, Commission Di rective 2003/63/EC amending Directive 2001/83/EC 
on the Community code relating to medicinal  products for human use, Directive 2004/24/EC of the 
European Parliament and of the Council amending, as regards traditional herbal medicinal products, 
Directive 2001/83/EC on the Community code relating to medicinal products for human use and  Directive 
2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the 
Community code relating to medicinal products for human use”. 
17. In the Medicines for Human Use (Clinical Trials) Regulations 2004( b), in regulation 2 (interpretation), 
in paragraph (1)— 
(a) in the definition of “Directive 2001/83/EC” after  “as amended” insert “by Directive 2002/98/EC of 
the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage  and distribution of human blood and blood components, 
Commission Directive 2003/63/EC amending Direc tive 2001/83/EC on the Community code 
relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and 
of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on 
the Community code relating to medicinal products for human use and  Directive 2004/27/EC of the 
European Parliament and of the Council amending Directive 2001/83/EC on the Community code 
relating to medici nal products for human use”, 
(b) in the definition of “marketing authorization”, in paragraph (c), after “Council Regulation (EEC) 
2309/93”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and of the Council 
laying down Community procedures for the authorisa tion and supervision of medicinal products for 
human and veterinary use and establis hing a European Medicines Agency”. 
18. In the General Product Safety Regulations 2005( c) in regulation 33 (duty to notify), in paragraph 
(10)(b), after “human use”, insert  “as amended by Directive 2002/98/EC of the European Parliament and of 
the Council setting standards of quality and safety for the collection, testing, processing, storage and 
distribution of human blood and blood components, Commission Directiv e 2003/63/EC amending Directive 
2001/83/EC on the Community code relating to medi cinal products for human use, Directive 2004/24/EC of 
the European Parliament and of the Council amending, as regards traditional herbal  medicinal products, 
Directive 2001/83/EC on the Community code relating to medicinal products for human use and  Directive 
2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the 
Community code relating to medicinal products for human use”. 
                                                                                                                                                                               
 
(a) S.I. 2004/478. 
(b) S.I. 2004/1031. 
(c) S.I. 2005/1803.  1319. In Schedule 13 to the Enterprise Act 2002( a), for paragraph 11 substitute the following— 
“11. Articles 83 to 100 of the Directive 2001/83/EC of the European Parliament and of the Council 
of 6 November 2001 on the Community Code rela ting to medicinal products for human use as read 
with— 
(a) Directive 2004/24/EC of the European Parliament and of the Council amending, as regards 
traditional herbal medicinal  products, the code, and 
(d) Directive 2004/27/EC of the European Parliament and of the Council also amending the 
code.”. 
 
                                                                                                                                                                               
 
(a) c.40; relevant amending instrument is S.I. 2003/1374.  14 
EXPLANATORY NOTE 
(This note is not part  of the Regulations) 
These Regulations implement certain provisions of Directive 2004/27/EC of the European Parliament and 
of the Council (“the 2004 Directive”)( a) amending Directive 2001/83/EC on the Community code for 
medicinal products for human use (“the 2001 Directive”) and make certain transitional provisions. They also 
create offences in relation to the failure by certain persons to comply with obligations of the 2001 Directive 
or of Regulation (EC) No. 726/2004 of the European Parlia ment and of the Council laying down Community 
procedures for the authorisation and supervision of medi cinal products for human and veterinary use and 
establishing a European Medicines Agency (“Regula tion 726/2004”) and make consequential amendments 
to various enactments following the implementati on of the 2004 Directive and the adoption of Regulation 
726/2004. 
The 2001 Directive is implemented in part by th e Medicines for Human Use (Marketing Authorisations 
Etc.) Regulations 1994 (“the 1994 Regulations”).  Regulation 2 of these Regulations amends the 1994 
Regulations by updating references in those Regulations to the 2001 Di rective and Regulation 726/2004. 
Regulation 2 of these Regulations also makes amendmen ts to the 1994 Regulations consequential to the 
implementation of the 2004 Directive.  The definition of a “relevant medicinal product” is amended to 
exclude traditional herbal medi cinal products which are not required to  have a marketing authorization but 
will be required to be registered under the Medicines (Traditional Herbal Medicinal Products for Human 
Use) Regulations 2005.  Homoeopathic medicinal products which meet the conditions for the simplified 
scheme set up under Article 14(1) of the 2001 Directive are also excluded from the definition of a “relevant 
medicinal product”.  These products are governed by th e Medicines (Homoeopathic Medicinal Products for 
Human Use) Regulations 1994. 
Regulation 2(3) and (13) of these regulations amend regul ation 3 of, and Schedule 1 to, the 1994 
Regulations under which, unless an exception in Schedule 1 to those Regulations applies, it is an offence to 
place a medicinal product on the market or to distribute it by way of wholesale dealing unless a marketing 
authorization has been granted for the product by th e licensing authority or the European Commission. The 
effect of the amendment is that no such offence arises if  the product has an authorization granted by the 
licensing authority in accordance with Article 126a of the 2001 Directive which is inserted into the Directive 
by Article 1(84) of the 2004 Directive. Paragraphs (7)(b), (8), (9), (10), (11), (12) and (13)(c) of regulation 2 and regulation 4 of, and paragraphs 1 and 6 of the Sched ule to, these Regulati ons amend various enactments 
to ensure that they apply to products authorized under Article 126a in the same way as they apply to 
products which have a marketing authorization and to ensure that certain obligations which apply to the 
holder of a marketing authorization also apply to a person who holds an authorization granted in accordance 
with Article 126a of the 2001 Directive. 
Regulations 2(4) and (14)(a) amend regulation 3A of,  and paragraph 1A of Schedule 3 to, the 1994 
Regulations so that the borderline procedure applies to all products to which the 2001 Directive applies, i.e. 
including traditional herbal medi cinal products and homoeopathi c medicinal products which meet the 
conditions for the Article 14(1) simplified scheme. 
Regulation 2(5) of these Regulations inserts a new regula tion 3B into the 1994 Regulations to give effect 
to Article 5(3) of the 2001 Directive inserted by Ar ticle 1(4) of the 2004 Directive to exempt marketing 
authorization holders and others from civil liability  arising from a recommendation or requirement of a 
competent authority to use in certain circumstances an authorized medicinal product for an unauthorized 
indication or to use an unauthorized medicinal product. 
Regulation 2(6) of these Regulations amends regulation 4 of the 1994 Re gulations, which make provision 
for applications for the grant, renewal and variati on of UK marketing authorizations. The amendments 
implement Article 1(8) of the 2004 Directive, which substitutes Article 10 of the 2001 Directive, which is 
                                                                                                                                                                              
 
 
(a) Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products , 
Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ No. L136, 30.4.2004, p.85.  15concerned with applications for marketi ng authorizations for “generic medici nal products”. In addition they 
remove the requirement to provide 26 copies of an application and accompanying material. 
Regulation 2(7) of these Regulations amends regulation 5 of the 1994 Regulations. These give effect to the 
provisions concerning the renewal and validity of marke ting authorizations in Article 24 of the 2001 
Directive, as replaced by Article 1(23) of Directive 224/27/EC and provide for the period of validity of an 
authorization granted in accordance with Article 126a of the 2001 Directive. 
Regulation 2(13)(a) and (b) of these Regulations amends paragraphs 1 and 2 of Schedule 1 to the 1994 
Regulations, which implement Article 5(1) of the 2001 Directive, so as to provide that products which may 
be supplied without a marketing authorization in accordance with those paragraphs must be supplied in order 
to fulfil the special needs of indi vidual patients and, if manufactured or assembled in the UK or imported 
into the UK from a third country, must be manufactured, assembled or imported by the holder of a 
manufacturer’s licence relating to products to which paragraph 1 of Schedule 1 to the 1994 Regulations 
applies or have been manufactured, assembled or imported for the purposes of a clinical trial by the holder of 
a manufacturing authoriza tion for such products. 
Regulation 2(14) of these Regulations amends Schedule 3 to the 1994 Re gulations which create certain 
criminal offences in connection with the obligations of applicants for, and holders of, marketing 
authorizations and other persons ari sing under the relevant Community  provisions. The amendments create 
new offences for breaches of the new obligations inserted into the 2001 Directive by the amendments made 
by the 2004 Directive; in particular the amendments made by Article 1(8), (22), (57) and (76) of the 2004 Directive. In addition the amendments create new offences for breaches of obligations relating to 
Community marketing authorizations under Article s 13(4), 16 and 26 of Regulation (EC) No. 726/2004. 
Regulation 2(14)(i) amends Schedule 3, so as to extend th e offences relating to UK marketing authorizations 
to authorizations granted in accordance with new Article 126a of the 2001 Directive.  Regulation 2(14)(d) 
makes it a criminal offence for a person to distribute a relevant medicinal product by way of wholesale 
dealing, if it does not have a marketing authorization. 
Regulation 2(15) of these regulations amends the 1994 Regulations so as to make transitional provision for 
the application of the amendments relating to the labelling of medicinal products made by Article 1(40), (41) 
and (42) of the 2004 Directive. 
Regulation 3 of these Regulations amends section 60 of the Patents Act 1977 so as to implement Article 
10(6) of the 2001 Directive, substituted by Article 1(8) of the 2004 Directive, and Article 13(6) of Directive 
2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary 
medicinal products, substituted by Article 1(6) of Directive 2004/28/EC.  These Articles provide that the 
conduct of tests and trials for the purposes of Article 10(1) to (4) of the 2001 Directive (applications for generic medicinal products), and the consequential practi cal requirements, shall not be regarded as contrary 
to patent rights for medicinal products. 
Regulation 4 and the Schedule to these regulations make provision for consequential amendments to other 
enactments. 
A Regulatory Impact Assessment in rel ation to these Regulations, and a Transposition Note in relation to 
the implementation of the 2004 Directive, have been placed in the libraries of both Houses of Parliament and 
copies may be obtained from the Medicines and Hea lthcare products Regulatory Agency, Market Towers, 1 
Nine Elms Lane, London SW8 5NQ. £3.00 
¤ 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. 
E1411  10/2005 151411T  19585 ISBN 0-11-073423-8
9 780110 734231 
 
STATUTORY INSTRUMENTS 
2005 No. 2759 
MEDICINES 
The Medicines (Marketing Authorisations Etc.) Amendment 
Regulations 2005