Changes from plenary report to adopted text

AddedPharmacodynamic studies shall be designed and tailored to the specificities of tissue engineered products. The evidence for the ‘proof of concept’ and the kinetics of the product to obtain the intended regeneration, repairing or replacement shall be provided. Suitable pharmacodynamic markers, related to the intended function(s) and structure shall be taken into account.

Added5.4.3. Safety studies

AddedSection 5.3.3 shall apply.

AddedAnnex III

AddedCONDITIONS FOR QUALIFICATION OF A QUALIFIED PERSON

Added1. The qualified person shall hold a university degree in one or more of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology.

Added2. The qualified person shall have acquired practical full-time experience over at least two years, in one or more undertakings that are authorised manufacturers, obtaining sufficient knowledge of manufacture, testing, supply chains, good manufacturing practice and pharmaceutical quality systems as well as regulatory processes and dossier content for ensuring the quality of medicinal products.

Added3. A qualified person shall be in possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognised as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines: pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology.

AddedHowever, the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level.

AddedWhere two university courses or two courses recognised by the State as equivalent co-exist in a Member State and where one of these extends over four years and the other over three years, the three-year course leading to a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or its recognised equivalent shall be considered to fulfil the condition of duration referred to in the second subparagraph in so far as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognised as equivalent by the Member State in question.

AddedThe course shall include theoretical and practical study bearing upon at least the following basic subjects:

Added(a) Experimental physics

Added(b) General and inorganic chemistry

Added(c) Organic chemistry

Added(d) Analytical chemistry

Added(e) Pharmaceutical chemistry, including analysis of medicinal products

Added(f) General and applied biochemistry (medical)

Added(g) Physiology

Added(h) Micro biology

Added(i) Pharmacology

Added(j) Pharmaceutical technology

Added(k) Toxicology

Added(l) Pharmacognosy (study of the composition and effects of the natural active substances of plant and animal origin).

AddedStudies in these subjects should be so balanced as to enable the person concerned to fulfil the obligations specified in Article 153.

AddedIn so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in the first subparagraph do not fulfil the criteria laid down in this paragraph, the competent authority of the Member State shall ensure that the person concerned provides evidence of adequate knowledge of the subjects involved.

Added4. The qualified person shall have acquired practical experience over at least two years, in one or more undertakings or not-for-profit entities that are authorised to manufacture medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of medicinal products.

Added5. A person engaging in the activities of the person referred to in Article 152 from the time of the application of Second Council Directive 75/319/EEC1, in a Member State without complying with the provisions of this Annex shall be eligible to continue to engage in those activities within the Union.

Added6. The holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course — or a course recognised as equivalent by the Member State concerned — in a scientific discipline allowing them to engage in the activities of the person referred to in Article 48 in accordance with the laws of that Member State may — if they began their course prior to 21 May 1975 — be considered as qualified to carry out in that Member State the duties of the person referred to in Article 152 provided that they have previously engaged in the following activities for at least two years before 21 May 1985 following notification of this directive in one or more undertakings or not-for-profit entities authorised to manufacture: production supervision or qualitative and quantitative analysis of active substances, and the necessary testing and checking under the direct authority of the person referred to in Article 152 to ensure the quality of the medicinal products.

AddedAnnex IV

AddedLABELLING PARTICULARS

AddedThe following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:

Added(a) the name of the medicinal product, including in Braille, followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the medicinal product contains up to three active substances, the international non-proprietary name (INN) shall be included, unless it is already part of the name of the medicinal product, or, if one does not exist, the common name; [Am. 332]

Added(b) a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;

Added(c) the pharmaceutical form and the contents by weight, by volume or by number of doses of the medicinal product;

Added(d) a list of those excipients known to have a recognised action or effect and included in the detailed guidance published pursuant to Article 68;

Added(e) the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated;

Added(f) a special warning that the medicinal product must be stored out of the reach and sight of children;

Added(g) a special warning, if this is necessary for the medicinal product;

Added(ga) for antimicrobials, a warning that improper use and unsafe disposal of the medicinal product contributes to antimicrobial resistance; [Am. 333]

Added(h) the expiry date in clear terms (month/year);

Added(i) special storage precautions, if any;

Added(j) specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place; [Am. 334]

Added(k) the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent them;

Added(l) the number of the marketing authorisation for placing the medicinal product on the market;

Added(m) the manufacturer's batch number;

Added(n) in the case of non-prescription medicinal products, instructions for use;

Added(o) for medicinal products other than radiopharmaceuticals referred to in Article 67(1), safety features enabling wholesale distributors and persons authorised or entitled to supply medicinal products to the public to:

Added(i) verify the authenticity of the medicinal product, and

Added(ii) identify individual packs,

Added- as well as a device allowing verification of whether the outer packaging has been tampered with.

AddedAnnex V

AddedCONTENTS OF SUMMMARY PRODUCT CHARACTERISTICS

AddedThe summary of product characteristics shall contain, in the order indicated below, the following information:

Added(1) name of the medicinal product followed by the strength and the pharmaceutical form.

Added(2) qualitative and quantitative composition in terms of the active substances and of the excipient, knowledge of which is essential for proper administration of the medicinal product. The usual common name or chemical description shall be used.

Added(3) pharmaceutical form.

Added(4) clinical particulars:

Added(a) therapeutic indications,

Added(b) posology and method of administration for adults and, where necessary for children,

Added(c) contra-indications,