The Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations provide for the enforcement of Regulation (EC) No.1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products (“ATMPs”).

Regulation 2 disapplies section 7 of the Medicines Act 1968 (which is concerned with product licences for medicinal products which are not subject to the European Union law governing medicines) in relation to exempt ATMPs.

Regulation 3 gives effect to—

(a) Schedule 1 which sets out requirements which have effect as provisions of manufacturers’ licences insofar as they relate to exempt ATMPs;

(b) Schedule 2 which sets out requirements which may be incorporated in manufacturers’ licences insofar as they relate to exempt ATMPs;

(c) Schedule 3 which sets out requirements which have effect as provisions of wholesale dealers’ licences insofar as they relate to exempt ATMPs; and

(d) Schedule 4 which sets out requirements which may be incorporated in wholesale dealers’ licences insofar as they relate to exempt ATMPs.

Regulation 4 makes it an offence to treat a patient with an ATMP if there is not a system of patient and product traceability. It is a defence to that offence if the person is assured in writing that there is such a system in relation to the treatment. A person commits an offence if they provide such a written assurance when there is not a system in place in relation to such treatment.

Regulation 5 makes provision as to data relating to starting and raw materials of exempt ATMPs including substances coming into contact with the cells or tissues that exempt ATMPs may contain. It subjects a holder of a manufacturing licence in respect of an exempt ATMP to liability for a criminal offence if that person does not keep data required as part of a traceability system for 30 years or, in the event of that person’s bankruptcy or liquidation, transfer it to the licensing authority.

Regulation 6 amends the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 so that they do not apply in relation to exempt ATMPs.

Regulation 7 amends the Medicines (Applications for Manufacturer’s and Wholesale Dealer’s Licences) Regulations 1971 so that an applicant for a manufacturer’s licence which relates to exempt ATMPs must provide an outline of the arrangements for maintaining records to allow product traceability containing sufficient detail to enable linking a product to the patient who received it and vice versa.

Regulation 8 and Schedule 5 amend the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 to enable enforcement of the provisions of Regulation (EC) No 1394/2007 (other than in relation to exempt ATMPs).

They also give effect to the decision of the European Court of Justice in C-143/06 Ludwigs-Apotheke München Internationale Apotheke v Juers Pharma Import-Export GmbH by permitting price lists to be issued that do not make representations in respect of a 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 that person’s individual patients on that person’s direct personal responsibility, in order to fulfil the special needs of those patients. They also make an amendment to take into account an amendment to Directive 2001/83 of the European Parliament and of the Council by Commission Directive 2009/120/EC.

Regulation 9 amends the Medicines for Human Use (Clinical Trials) Regulations so that the procedures for giving an ethics committee opinion and for authorising clinical trials apply to trials involving tissue engineered products in the same way that they apply to trials involving gene therapy and somatic cell therapy. It also corrects an error in Schedule 2 to those Regulations.

Regulation 10 amends the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 so that they do not apply to ATMPs. It also gives effect to the decision of the European Court of Justice in C-143/06 by permitting holders of wholesale dealer’s licences or manufacturer’s licences to issue price lists that do not make representations in respect of a product to which paragraph 1 of Schedule 1 to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994.

These Regulations (other than the amendment resulting from Commission Directive 2009/120) have been notified to the European Commission and other Member States of the European Union in accordance with Directive 98/34/EC(1) of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations and rules on Information Society services, as amended by Article 1(4) of the European Parliament and Council Directive 98/48/EC(2) and Council Directive 2006/96/EC of 20 November 2006(3).

An Impact Assessment has been prepared in respect of these Regulations which is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

(1)

OJ No. L204, 21.7.1998, p.37.

(2)

OJ No. L217, 5.8.1998, p.18.

(3)

OJ No L.363, 20.12.2006, p.81.