Specific requirements for special groups of medicinal products
This Regulation shall not affect the application of national law prohibiting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from those cells, or of medicinal products used as abortifacients or of medicinal products containing narcotic substances within the meaning of the relevant international conventions in force such as the Single Convention on Narcotic Drugs of 1961 of the United Nations. The Member States shall communicate that national law to the Commission.
No gene therapy clinical trials may be carried out which result in modifications to the subject's germ line genetic identity.
Relation with other Union legislation
This Regulation shall be without prejudice to Council Directive 97/43/Euratom ( 13 ) , Council Directive 96/29/Euratom ( 14 ) , Directive 2001/18/EC of the European Parliament and of the Council ( 15 ) , Directive 2004/23/EC of the European Parliament and of the Council ( 16 ) , Directive 2002/98/EC of the European Parliament and of the Council ( 17 ) , Directive 2010/53/EC of the European Parliament and of the Council ( 18 ) , and Directive 2009/41/EC of the European Parliament and of the Council. ( 19 )
Investigational medicinal products, other products and procedures, free of charge for the subject
Without prejudice to the Member States' competence for the definition of their health policy and for the organisation and delivery of health services and medical care, the costs for investigational medicinal products, auxiliary medicinal products, medical devices used for their administration and procedures specifically required by the protocol shall not be borne by the subject, unless the law of the Member State concerned provides otherwise.
Data protection
1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.
2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission and the Agency pursuant to this Regulation.
Penalties
1. Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.
2. The rules referred to in paragraph 1 shall address, inter alia, the following:
(a)
non-compliance with the provisions laid down in this Regulation on submission of information intended to be made publicly available to the EU database;
(b)
non-compliance with the provisions laid down in this Regulation on subject safety.
Civil and criminal liability
This Regulation is without prejudice to national and Union law on the civil and criminal liability of a sponsor or an investigator.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
