47.—(1) The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(36) are amended as follows.
(2) In regulation 14 (fees for variation of certificates)—
(a) in paragraph (1)(a), for “£110” substitute “£127”;
(b) in paragraph (1)(b)(i), for £110” substitute “£127”;
(c) in paragraph (1)(b)(ii), for “£55” substitute “£63.50”;
(d) in paragraph (2)(a), for “£237” substitute “£250”;
(e) in paragraph (2)(b)(i), for “£237” substitute “£250”;
(f) in paragraph (2)(b)(ii), for “”£237” substitute “£250”;
(g) in paragraph 2(b)(iii), for “£120” substitute “£127”; and
(h) in paragraph 2(b)(iv), for “£60”, substitute “£62.50”.
(3) In regulation 15 (fees payable by holders of certificates), in paragraph (1), for “£19” substitute “£22”.
(4) In the table in Schedule 2 (fees for applications for the grant of certificates of registration)—
(a) in column (2) (fees for applications in respect of products prepared from not more than 5 homoeopathic stocks)—
(i) for “£155” substitute “£164”,
(ii) for “£466” substitute “£492”,
(iii) for “£488” substitute “£516”, and
(iv) for “£770” substitute “£813”.
(b) in column (3) (fees for other applications)—
(i) for “£383” substitute “£405”,
(ii) for “£686” substitute “£725”,
(iii) for “£622” substitute “£657”, and
(iv) for “£1,007” substitute “£1,064”.
(5) In Schedule 2A (fees for assistance in obtaining certificates of registration in other EEA States)(37), in paragraph 2—
(a) in sub-paragraph (a), for “£279” substitute “£295”; and
(b) in sub-paragraph (b), for “£365” substitute “£386”.
48.—(1) The Regulations listed in Schedule 7 are revoked to the extent specified in that Schedule.
(2) But—
(a) in relation to capital fees, the Medicines (Products for Human Use – Fees ) Regulations 1995(38) continue to apply as if they had not been revoked to any application or inspection made before the date on which these Regulations come into force;
(b) the Medicines (Products for Human Use – Fees ) Regulations 1995 continue to apply as if they had not been revoked to any periodic fee payable in relation to a fee period ending before the date on which these Regulations come into force;
(c) paragraph (1) does not affect any proceedings constituted under the revoked Regulations for the recovery of any fees due as debts to the Crown.
(3) For the purpose of this regulation “capital fee” and “periodic fee” have the same meaning as is given in the Medicines (Products for Human Use – Fees ) Regulations 1995.
Signed by authority of the Secretary of State for Health.
Dawn Primarolo
Minister for Health,
Department of Health
27th February 2008
Michael McGimpsey
Minister for Health, Social Services and Public Safety
27th February 2008
Michelle Gildernew
Minister for Agriculture and Rural Development
28th February 2008
Alan Campbell
Steve McCabe
Two of the Lords Commissioners of Her Majesty’s Treasury
26th February 2008
Regulations 2 (1), 12 (1) (a), 16, 18(1), 19 (1), 22(1), 26(1).
1. In this Schedule—
“active ingredient” means an ingredient of a medicinal product in respect of which efficacy is claimed (whether therapeutic, diagnostic or otherwise);
“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 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;
“certificate of registration” means a certificate for the purposes of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(39);
“complex application” means an application, other than a major application, for a marketing authorization where the application falls within one or more of the descriptions specified in sub-paragraphs (a) to (s)—
the application relates to a medicinal product which is intended to be used in accordance with an indication for use in respect of a new category of patients or as treatment for a new category of disease;
the application relates to a medicinal product containing a new combination of active ingredients that have not previously been included in that combination in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
the application relates to a medicinal product containing a new excipient;
the application relates to a medicinal product that is intended to be administered by a route of administration different from that used in the administration of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
the application relates to a medicinal product containing an active ingredient the manufacture of which involves a route of synthesis (or, in the case of a medicinal product not synthetically produced, a method of manufacture) different from that used in the manufacture of the active ingredient of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
the application relates to a medicinal product which is a controlled release preparation and is not a simple application;
the application relates to a sterile medicinal product the manufacture of which involves a method of sterilisation different from that used in the manufacture of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
the application relates to a sterile medicinal product the container of which is directly in contact with the medicinal product and is made from different material from the container of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
unless a European Pharmacopoeia certificate of suitability covering the active ingredient has been submitted with the application, the application names as manufacturer of the active ingredient of the medicinal product in question a different manufacturer from the manufacturer of that active ingredient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
the application relates to a medicinal product which is an influenza vaccine and in respect of which the manufacturer or the manufacturing process is different from that specified in any other marketing authorization which the application holds in respect of that product;
the application is for the grant of a marketing authorization for a medicinal product which is an influenza vaccine, except where it relates only to an influenza vaccine containing a different strain or strains from that specified in any other marketing authorization which the applicant holds;
the application is for the grant of a marketing authorization for a medicinal product which is to be delivered by way of a metered dose inhaler;
the application is for the grant of a marketing authorization for a medicinal product which is in a powdered form and is to be delivered by way of inhalation;
the application relates to a medicinal product—
which is administered to the site of action or absorption by a method which has not previously been authorised in relation to any authorised medicinal product which contains the same active ingredient as the product in question, and
in respect of that other product, a marketing authorization (other than a product licence of right) has previously been granted;
the application is an application for a marketing authorization to which Article 10(3) of the 2001 Directive applies;
the application is an application where the sole or primary evidence for the safety and efficacy of the medicinal product consists of published scientific literature;
the application is—
for an extension of an existing marketing authorization which fulfils the conditions set out in Annex II to Commission Regulation (EC) No. 1084/2003, and
includes the result of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive;
the application—
is not an application in accordance with Article 10, 10a or 10c of the 2001 Directive, and
includes the results of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive;
the application is an application for a marketing authorization to which the first sub-paragraph of paragraph 3 of Part II of Annex I to the 2001 Directive applies;
“complex registration application” means an application for a traditional herbal registration relating to a medicinal product containing an active ingredient that has not previously been included as an active ingredient 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;
“decentralised procedure application” means a major application, a complex application, a standard application or a simple application for a marketing authorization for a medicinal product in respect of which at the time of the application—
a marketing authorization has not been granted in any EEA State; and
an application for a marketing authorization has been made in more than one EEA State pursuant to the procedure in Title III, Chapter 4 of the 2001 Directive;
“EC marketing authorization” means—
a marketing authorization, or
an authorization issued by the competent authorities of an EEA State other than the United Kingdom for the purposes of Article 6 of the 2001 Directive;
“eCTD format” means the electronic format of the Common Technical Document referred to in the guidance published by the European Commission in Volume 2B of “The Rules Governing Medicinal Products in the European Union”, referred to in paragraph (1) of the Introduction to Annex I to the 2001 Directive;
“eCTD format application” means an application made using the MHRA portal and in relation to which the accompanying particulars and documents are presented in eCTD format;
“European reference product application” means an application for a marketing authorization to which the third sub-paragraph of Article 10(1) of the 2001 Directive applies;
“major application” means an application for a marketing authorization relating to a medicinal product containing a new active ingredient;
“the MHRA portal” means the internet-based hosted platform which enables persons to carry out business with the Medicines and Healthcare products Regulatory Agency of the Department of Health electronically, known as the “the MHRA Portal”;
“mutual recognition procedure incoming application” means a major application, a complex application, or a standard application for a marketing authorization for a medicinal product in respect of which—
a marketing authorization has already been granted in another EEA State; and
recognition of that marketing authorization is sought from the licensing authority by way of the grant of a marketing authorization in the United Kingdom, pursuant to the procedure in Title III, Chapter 4 of the 2001 Directive;
“new active ingredient” means an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;
“new excipient” means—
except in Part 2, paragraph 11 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product—
which is intended to be administered by the same route of administration as the product in question, and
in respect of which a marketing authorization (other than a product licence or right), a certificate of registration or a traditional herbal registration has previously been granted,
except that in the case of a medicinal product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Community) as an approved ingredient or additive in food or in a food product;
in Part 2, paragraph 11 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product which is intended to be administered by the same route of administration as the product in question and in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted, except that—
in the case of a medicinal product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Community) as an approved ingredient or additive in food or in a food product, and
in the case of a medicinal product intended for external use only, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Community) as an approved ingredient or additive in a cosmetic product;
“Phase I trial” means a clinical trial to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial;
“Phase II or Phase III trial” means a clinical trial, other than a Phase I trial, where the medicinal product being tested—
does not have an EC marketing authorization; or
has an EC marketing authorization, but—
there has been a change—
to the process of manufacture of the product or its active ingredient, or
of manufacturer of that product or substance, or
the product is to be used in the trial other than in accordance with the terms of the summary of product characteristics under that authorization;
“Phase IV trial” means a clinical trial other than a Phase I trial or a Phase II or Phase III trial;
“reduced registration application category I” means an application other than a complex registration application for a traditional herbal registration relating to a medicinal product which is presented in the form of a herbal tea;
“reduced registration application category II” means an application, other than a complex registration application, or a traditional herbal registration where the application falls within one of the descriptions specified in sub-paragraphs (a) to (d) as follows—
the application relates to a medicinal product which is presented in the form of a herbal tincture;
the application relates to a medicinal product which is presented in the form of an essential oil;
the application relates to a medicinal product which is presented in the form of a fatty oil; or
the application relates to a medicinal product which contains only herbal substances in a capsule;
“simple application” means—
an application for a marketing authorization to which Article 10c of the 2001 Directive applies; or
an application made no later than three months after the expiry of a marketing authorization, which is for a marketing authorization containing identical provisions to those contained in the expired authorization and which is made by the person who held the expired authorization;
“standard application” means any application for the grant of a marketing authorization which is not a major application, a complex application, a simple application, a change of ownership application or an application for a parallel import licence;
“standard registration application” means any application for the grant of a traditional herbal registration which is not a complex registration application, a reduced registration application category I, a reduced registration application category II or a change of ownership application;
“TSE risk ingredient from a new source” and “TSE risk excipient from a new source” mean an active ingredient or excipient, respectively, which has been manufactured from raw materials of ruminant origin or which has had raw materials of ruminant origin used in its manufacture and in respect of which—
the application names as manufacturer a manufacturer not previously named as the manufacturer of that ingredient or excipient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted; and
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 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.
S.I. 1994/105; relevant amending instruments are S.I. 1996/482, 1998/574, 1999/566, 2003/625, 2005/2753, 2006/494 and 2007/610 and 803. Back [36]
Schedule 2A was inserted by S.I. 2005/2753 and amended by S.I. 2007/610. Back [37]
S.I. 1994/105; relevant amending instruments are S.I. 1996/482, 2005/2753, 2006/494 and 2007/610. Back [39]
Amended by correction slip on 01 March 2008