Article 32
1. When reference is made to the procedure laid down in this Article, the Committee shall consider the matter concerned and shall issue a reasoned opinion within 60 days of the date on which the matter was referred to it. However, in cases submitted to the Committee in accordance with Articles 30 and 31, this period may be extended by the Committee for a further period of up to 90 days, taking into account the views of the applicants or the marketing authorisation holders concerned. In an emergency, and on a proposal from its Chairman, the Committee may agree to a shorter deadline. 2. In order to consider the matter, the Committee shall appoint one of its members to act as rapporteur. The Committee may also appoint individual experts to advise it on specific questions. When appointing experts, the Committee shall define their tasks and specify the time-limit for the completion of these tasks. 3. Before issuing its opinion, the Committee shall provide the applicant or the marketing authorisation holder with an opportunity to present written or oral explanations within a time limit which it shall specify. The opinion of the Committee shall be accompanied by a draft summary of product characteristics for the product and a draft text of the labelling and package leaflet. If necessary, the Committee may call upon any other person to provide information relating to the matter before it. The Committee may suspend the time-limits referred to in paragraph 1 in order to allow the applicant or the marketing authorisation holder to prepare explanations. 4. The Agency shall forthwith inform the applicant or the marketing authorisation holder where the opinion of the Committee is that: (a) the application does not satisfy the criteria for authorisation; or (b) the summary of the product characteristics proposed by the applicant or the marketing authorisation holder in accordance with Article 11 should be amended; or (c) the authorisation should be granted subject to certain conditions, in view of conditions considered essential for the safe and effective use of the medicinal product including pharmacovigilance; or (d) a marketing authorisation should be suspended, varied or revoked. Within 15 days after receipt of the opinion, the applicant or the marketing authorisation holder may notify the Agency in writing of his intention to request a re-examination of the opinion. In that case, he shall forward to the Agency the detailed grounds for the request within 60 days after receipt of the opinion. Within 60 days following receipt of the grounds for the request, the Committee shall re-examine its opinion in accordance with the fourth subparagraph of Article 62(1) of Regulation (EC) No 726/2004. The reasons for the conclusion reached shall be annexed to the assessment report referred to in paragraph 5 of this Article. 5. Within 15 days after its adoption, the Agency shall forward the final opinion of the Committee to the Member States, to the Commission and to the applicant or the marketing authorisation holder, together with a report describing the assessment of the medicinal product and stating the reasons for its conclusions. In the event of an opinion in favour of granting or maintaining an authorisation to place the medicinal product concerned on the market, the following documents shall be annexed to the opinion: (a) a draft summary of the product characteristics, as referred to in Article 11; (b) any conditions affecting the authorisation within the meaning of paragraph 4(c); (c) details of any recommended conditions or restrictions with regard to the safe and effective use of the medicinal product; (d) the proposed text of the labelling and leaflet." 27) Article 33 shall be amended as follows: (a) in the first paragraph, "30 days" shall be replaced by "15 days"; (b) in the second paragraph, "Article 32(5)(a) and (b)" shall be replaced by "Article 32(5), second subparagraph"; (c) in the fourth paragraph, the words "or the marketing authorisation holder" shall be added after the word "applicant"; 28) Article 34 shall be replaced by the following: "Article 34 1. The Commission shall take a final decision in accordance with, and within 15 days after the end of, the procedure referred to in Article 121(3). 2. The rules of procedure of the Standing Committee established by Article 121(1) shall be adjusted to take account of the tasks incumbent upon it under this Chapter. Those adjustments shall entail the following provisions: (a) except in cases referred to in the third paragraph of Article 33, the opinion of the Standing Committee shall be given in writing; (b) Member States shall have 22 days to forward their written observations on the draft decision to the Commission. However, if a decision has to be taken urgently, a shorter time-limit may be set by the Chairman according to the degree of urgency involved. This time-limit shall not, otherwise than in exceptional circumstances, be shorter than 5 days; (c) Member States shall have the option of submitting a written request that the draft Decision be discussed in a plenary meeting of the Standing Committee. Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion delivered by the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration. The provisions necessary for the implementation of this paragraph shall be adopted by the Commission in accordance with the procedure referred to in Article 121(2). 3. The decision as referred to in paragraph 1 shall be addressed to all Member States and reported for information to the marketing authorisation holder or applicant. The concerned Member States and the reference Member State shall either grant or revoke the marketing authorisation, or vary its terms as necessary to comply with the decision within 30 days following its notification, and they shall refer to it. They shall inform the Commission and the Agency accordingly."; 29) the third subparagraph of Article 35(1) shall be deleted; 30) in Article 38, paragraph 2 shall be replaced by the following: "2. At least every ten years the Commission shall publish a report on the experience acquired on the basis of the procedures described in this Chapter and shall propose any amendments which may be necessary to improve those procedures. The Commission shall submit this report to the European Parliament and to the Council."; 31) Article 39 shall be replaced by the following: "Article 39 Article 29(4), (5) and (6) and Articles 30 to 34 shall not apply to the homeopathic medicinal products referred to in Article 14. Articles 28 to 34 shall not apply to the homeopathic medicinal products referred to in Article 16(2)."; 32) the following paragraph shall be added to Article 40: "4. The Member States shall forward to the Agency a copy of the authorisation referred to in paragraph 1. The Agency shall enter that information on the Community database referred to in Article 111(6)."; 33) in Article 46, point (f) shall be replaced by the following: "(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials. This point shall also be applicable to certain excipients, the list of which as well as the specific conditions of application shall be established by a Directive adopted by the Commission in accordance with the procedure referred to in Article 121(2)."; 34) the following Article shall be inserted: "Article 46a 1. For the purposes of this Directive, manufacture of active substances used as starting materials shall include both total and partial manufacture or import of an active substance used as a starting material as defined in Part I, point 3.2.1.1 (b) Annex I, and the various processes of dividing up, packaging or presentation prior to its incorporation into a medicinal product, including repackaging or re-labelling, such as are carried out by a distributor of starting materials. 2. Any amendments necessary to adapt paragraph 1 to new scientific and technical developments shall be laid down in accordance with the procedure referred to in Article 121(2)."; 35) in Article 47, the following paragraphs shall be added:"The principles of good manufacturing practice for active substances used as starting materials referred to in point (f) of Article 46 shall be adopted in the form of detailed guidelines. The Commission shall also publish guidelines on the form and content of the authorisation referred to in Article 40(1), on the reports referred to in Article 111(3) and on the form and content of the certificate of good manufacturing practice referred to in Article 111(5)."; 36) in Article 49(1), "minimum" shall be deleted; 37) in Article 49(2), fourth subparagraph, first indent "Applied physics" shall be replaced by "Experimental physics"; 38) in Article 50(1), "in the State concerned" shall be replaced by "within the Community"; 39) in Article 51(1), point (b) shall be replaced by the following: "(b) in the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the Community, that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation."; 40) Article 54 shall be amended as follows: (a) point (a) shall be replaced by the following: "(a) the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name;"; (b) in point (d), "guidelines" shall be replaced by "detailed guidance"; (c) Point (e) shall be replaced by the following: "(e) the method of administration and, if necessary, the route of administration. Space shall be provided for the prescribed dose to be indicated."; (d) point (f) shall be replaced by the following: "(f) a special warning that the medicinal product must be stored out of the reach and sight of children;"; (e) Point (j) shall be replaced by the following: "(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;"; (f) point (k) shall be replaced by the following: "(k) the name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him;"; (g) point (n) shall be replaced by the following: "(n) in the case of non-prescription medicinal products, instructions for use"; 41) Article 55 shall be amended as follows: (a) in paragraph 1, "in Articles 54 and 62" shall be replaced by "in Article 54"; (b) the first indent of paragraph 2 shall be replaced by the following: "- the name of the medicinal product as laid down in point (a) of Article 54,"; (c) the first indent of paragraph 3 shall be replaced by the following: "- the name of the medicinal product as laid down in point (a) of Article 54 and, if necessary, the route of administration,"; 42) the following Article shall be inserted: "Article 56a The name of the medicinal product, as referred to in Article 54, point (a) must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patients' organisations in formats appropriate for the blind and partially-sighted." 43) in Article 57, the following paragraph shall be added:"For medicinal products authorised under Regulation (EC) No 726/2004, Member States shall, when applying this Article, observe the detailed guidance referred to in Article 65 of this Directive."; 44) Article 59 shall be replaced by the following: "Article 59 1. The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order: (a) for the identification of the medicinal product: (i) the name of the medicinal product followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults. The common name shall be included where the product contains only one active substance and if its name is an invented name; (ii) the pharmaco-therapeutic group or type of activity in terms easily comprehensible for the patient; (b) the therapeutic indications; (c) a list of information which is necessary before the medicinal product is taken: (i) contra-indications; (ii) appropriate precautions for use; (iii) forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product; (iv) special warnings; (d) the necessary and usual instructions for proper use, and in particular: (i) the dosage, (ii) the method and, if necessary, route of administration; (iii) the frequency of administration, specifying if necessary the appropriate time at which the medicinal product may or must be administered; and, as appropriate, depending on the nature of the product: (iv) the duration of treatment, where it should be limited; (v) the action to be taken in case of an overdose (such as symptoms, emergency procedures); (vi) what to do when one or more doses have not been taken; (vii) indication, if necessary, of the risk of withdrawal effects; (viii) a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product; (e) a description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; the patient should be expressly asked to communicate any adverse reaction which is not mentioned in the package leaflet to his doctor or pharmacist; (f) a reference to the expiry date indicated on the label, with: (i) a warning against using the product after that date; (ii) where appropriate, special storage precautions; (iii) if necessary, a warning concerning certain visible signs of deterioration; (iv) the full qualitative composition (in active substances and excipients) and the quantitative composition in active substances, using common names, for each presentation of the medicinal product; (v) for each presentation of the product, the pharmaceutical form and content in weight, volume or units of dosage; (vi) the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the Member States; (vii) the name and address of the manufacturer; (g) where the medicinal product is authorised in accordance with Articles 28 to 39 under different names in the Member States concerned, a list of the names authorised in each Member State; (h) the date on which the package leaflet was last revised. 2. The list set out in point (c) of paragraph 1 shall: (a) take into account the particular condition of certain categories of users (children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions); (b) mention, if appropriate, possible effects on the ability to drive vehicles or to operate machinery; (c) list those excipients knowledge of which is important for the safe and effective use of the medicinal product and which are included in the detailed guidance published pursuant to Article 65. 3. The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use."; 45) Article 61(1) shall be replaced by the following: "1. One or more mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the authorities competent for authorising marketing when the marketing authorisation is requested. The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority."; 46) in Article 61(4), "or as appropriate" shall be replaced by "and"; 47) in Article 62, "for health education" shall be replaced by "for the patient"; 48) Article 63 shall be amended as follows: (a) the following subparagraph shall be added to paragraph 1:"In the case of certain orphan medicinal products, the particulars listed in Article 54 may, on reasoned request, appear in only one of the official languages of the Community."; (b) paragraphs 2 and 3 shall be replaced by the following: "2. The package leaflet must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary with the help of health professionals. The package leaflet must be clearly legible in the official language or languages of the Member State in which the medicinal product is placed on the market. The first subparagraph shall not prevent the package leaflet from being printed in several languages, provided that the same information is given in all the languages used. 3. When the product is not intended to be delivered directly to the patient, the competent authorities may grant an exemption to the obligation that certain particulars should appear on the labelling and in the package leaflet and that the leaflet must be in the official language or languages of the Member State in which the product is placed on the market."; 49) Article 65 shall be replaced by the following: "Article 65 In consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning in particular: (a) the wording of certain special warnings for certain categories of medicinal products; (b) the particular information needs relating to non-prescription medicinal products; (c) the legibility of particulars on the labelling and package leaflet; (d) the methods for the identification and authentication of medicinal products; (e) the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated; (f) harmonised provisions for the implementation of Article 57."; 50) Article 66(3), fourth indent shall be replaced by: "- the name and address of the manufacturer,"; 51) Article 69(1) shall be amended as follows: (a) the first indent shall be replaced by the following: "- the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1(5); if the homeopathic medicinal product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name"; (b) the last indent shall be replaced by the following: "- a warning advising the user to consult a doctor if the symptoms persist"; 52) Article 70(2) shall be amended as follows: (a) point (a) shall be replaced by the following: "(a) medicinal products on medical prescription for renewable or non-renewable delivery;"; (b) point (c) shall be replaced by the following: "(c) medicinal products on 'restricted' medical prescription, reserved for use in certain specialised areas."; 53) Article 74 shall be replaced by the following: "Article 74 When new facts are brought to their attention, the competent authorities shall examine and, as appropriate, amend the classification of a medicinal product by applying the criteria listed in Article 71."; 54) the following Article shall be inserted: "Article 74a Where a change of classification of a medicinal product has been authorised on the basis of significant pre-clinical tests or clinical trials, the competent authority shall not refer to the results of those tests or trials when examining an application by another applicant for or holder of marketing authorisation for a change of classification of the same substance for one year after the initial change was authorised."; 55) Article 76 shall be amended as follows: (a) the existing text shall become paragraph 1; (b) the following paragraphs shall be added: "2. In the case of wholesale distribution and storage, medicinal products shall be covered by a marketing authorisation granted pursuant to Regulation (EC) No 726/2004 or by the competent authorities of a Member State in accordance with this Directive. 3. Any distributor, not being the marketing authorisation holder, who imports a product from another Member State shall notify the marketing authorisation holder and the competent authority in the Member State to which the product will be imported of his intention to import it. In the case of products which have not been granted an authorisation pursuant to Regulation (EC) No 726/2004, the notification to the competent authority shall be without prejudice to additional procedures provided for in the legislation of that Member State."; 56) the second indent of point (e) of Article 80 shall be replaced by the following: "- name of the medicinal product,"; 57) Article 81 shall be replaced by the following: "Article 81 With regard to the supply of medicinal products to pharmacists and persons authorised or entitled to supply medicinal products to the public, Member States shall not impose upon the holder of a distribution authorisation which has been granted by another Member State any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorised to engage in equivalent activities. The holder of a marketing authorisation for a medicinal product and the distributors of the said medicinal product actually placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. The arrangements for implementing this Article should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition."; 58) in Article 82, the second indent of the first paragraph shall be replaced by the following: "- the name and pharmaceutical form of the medicinal product,"; 59) Article 84 shall be replaced by the following: "Article 84 The Commission shall publish guidelines on good distribution practice. To this end, it shall consult the Committee for Medicinal Products for Human Use and the Pharmaceutical Committee established by Council Decision 75/320/EEC(13)."; 60) Article 85 shall be replaced by the following: "Article 85 This Title shall apply to homeopathic medicinal products."; 61) the fourth indent of Article 86(2) shall be replaced by the following: "- information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products"; 62) Article 88 shall be replaced by the following: "Article 88 1. Member States shall prohibit the advertising to the general public of medicinal products which: (a) are available on medical prescription only, in accordance with Title VI; (b) contain substances defined as psychotropic or narcotic by international convention, such as the United Nations Conventions of 1961 and 1971. 2. Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary. 3. Member States shall be entitled to ban, on their territory, advertising to the general public of medicinal products the cost of which may be reimbursed. 4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States. 5. The prohibition referred to in paragraph 1 shall apply without prejudice to Article 14 of Directive 89/552/EEC. 6. Member States shall prohibit the direct distribution of medicinal products to the public by the industry for promotional purposes."; 63) the following text is inserted after Article 88: "TITLE VIIIa INFORMATION AND ADVERTISING