Article 2
The provisions of this Directive shall apply to industrially produced medicinal products for human use intended to be placed on the market in Member States.
Directive 2001/83/EC of the European Parliament and of the… TITLE II — SCOPE
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Article 3
This Directive shall not apply to: 1. Any medicinal product prepared in a pharmacy in accordance with a medical prescription for an individual patient (commonly known as the magistral formula). 2. Any medicinal product which is prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and is intended to be supplied directly to the patients served by the pharmacy in question (commonly known as the official formula). 3. Medicinal products intended for research and development trials. 4. Intermediate products intended for further processing by an authorized manufacturer. 5. Any radionuclides in the form of sealed sources. 6. Whole blood, plasma or blood cells of human origin.
Article 4
1. Nothing in this Directive shall in any way derogate from the Community rules for the radiation protection of persons undergoing medical examination or treatment, or from the Community rules laying down the basic safety standards for the health protection of the general public and workers against the dangers of ionizing radiation. 2. This Directive shall be without prejudice to Council Decision 86/346/EEC of 25 June 1986 accepting on behalf of the Community the European Agreement on the Exchange of Therapeutic Substances of Human Origin(20). 3. The provisions of this Directive shall not affect the powers of the Member States' authorities either as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of health, economic and social conditions. 4. This Directive shall not affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products as contraceptives or abortifacients. The Member States shall communicate the national legislation concerned to the Commission.
Article 5
A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorized health care professional and for use by his individual patients on his direct personal responsibility. TITLE III PLACING ON THE MARKET CHAPTER 1 Marketing authorization
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