Official Journal of the European Union
or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5. A delegated act adopted pursuant to Articles 27, 39, 45, 63(1) and 70 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months from notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or the Council.
CHAPTER XVIII
MISCELLANEOUS PROVISIONS
Article 90
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.
Article 91
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)
Article 92
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.
Article 93
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.
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