What changed between the plenary report and the adopted text

Added:(c) the legal status for supply to the patient, in accordance with Chapter IV;

Added:(d) authenticity and identification in accordance with Article 67(5).

Added:2. For medicinal products for which a centralised marketing authorisation as referred to in Article 5 has been granted, Member States shall, when applying this Article, observe the detailed guidance referred to in Article 77.

Added:Article 73 Symbols and pictogram

Added:The outer packaging, the immediate packaging and the package leaflet may include symbols or pictograms designed to clarify certain information set out in Articles 64(1), 65 and 69 and 65 and other information compatible with the summary of product characteristics that is useful for the patient, to the exclusion of any element of a promotional nature. [Am. 193]

Added:Article 74 Requirements on languages

Added:1. The particulars for labelling listed in Articles 64 and 65, shall appear in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.

Added:2. Paragraph 1 shall not prevent those particulars from being indicated in several languages, provided that the same particulars appear in all the languages used.

Added:3. The package leaflet must be clearly legible in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State.

Added:4. The competent authorities of the Member State may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where the medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State. Where a competent authority grants a full or partial exemption to the language requirements that apply to the label or package leaflet, the patients’ right to a printed copy in the official language or official languages of the Member State shall be guaranteed upon request and free of charge. [Am. 194]

Added:For the purpose of multi-language packages, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi-language package is marketed.

Added:Article 75 Member States exemptions from requirements for labelling and package leaflet

Added:The competent authorities of the Member States may, subject to measures they consider necessary to safeguard public health, grant an exemption to the obligation that the particulars required in Articles 64 and 65 should appear on the labelling and in the package leaflet in the following cases:

Added:(a) where the medicinal product is not intended to be delivered directly to the patient;

Added:(b) where there are problems in respect of the availability of the medicinal product;

Added:(c) where there are space constraints due to the size of the packaging or of the package leaflet or in case of multilingual packages or package leaflets;

Added:(d) in the context of a public health emergency;

Added:(e) to facilitate access to medicines in Member States.

Added:Article 76 Approval of the labelling and package leaflet information

Added:1. One or more mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the package leaflet, shall be submitted to the competent authorities 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.

Added:2. The competent authority shall refuse the marketing authorisation if the labelling or the package leaflet do not comply with the provisions of this Chapter or if they are not in accordance with the particulars listed in the summary of product characteristics.

Added:3. All proposed changes to an aspect of the labelling or the package leaflet covered by this Chapter and not connected with the summary of product characteristics shall be submitted to the competent authorities. If the competent authorities have not opposed a proposed change within 90 days following the introduction of the request, the applicant may put the change into effect.

Added:4. The fact that the competent authority does not refuse a marketing authorisation pursuant to paragraph 2 or a change to the labelling or the package leaflet pursuant to paragraph 3 does not alter the general legal liability of the manufacturer and the marketing authorisation holder.

Added:Article 77 Guidance on labelling particulars

Added:In consultation with the Member States and the parties concerned, the Commission shall draw up and publish detailed guidance concerning in particular:

Added:(a) the wording of certain special warnings for certain categories of medicinal products;

Added:(aa) the wording on prudent use and safe disposal of antimicrobials; [Am. 195]

Added:(b) the particular information needs relating to non-prescription medicinal products;

Added:(c) the legibility of particulars on the labelling and package leaflet;

Added:(d) the methods for the identification and authentication of medicinal products;

Added:(e) the list of excipients that must feature on the labelling of medicinal products and the way in which these excipients must be indicated;

Added:(f) harmonised provisions for the implementation of Article 72.

Added:Article 78 Placing on the market of labelled medicinal products

Added:Member States may not prohibit or impede the placing on the market of medicinal products within their territory on grounds connected with labelling or the package leaflet where these comply with the requirements of this Chapter.

Added:Article 79 Non-compliance with the requirements for labelling and package leaflet

Added:Where the provisions of this Chapter are not complied with, and a notice served on the marketing authorisation holder concerned has remained without effect, the competent authorities of the Member States may suspend the marketing authorisation, until the labelling and the package leaflet of the medicinal product in question have been made to comply with the requirements of this Chapter.

Added:Chapter VII Regulatory protection, unmet medical needs and rewards for paediatric medicinal products

Added:Article 80 Regulatory data and market protection

Added:1. The data referred to in Annex I, originally submitted with the view to obtaining a marketing authorisation shall not be referred to by another applicant for a subsequent marketing authorisation during the period determined in accordance with Article 81 (‘regulatory data protection period’).

Added:2. A medicinal product concerned by a subsequent marketing authorisation referred to in paragraph 1 shall not be placed on the market for a period of two years after the expiry of the relevant regulatory data protection periods referred to in Article 81.

Added:2a. The period referred in paragraph 2 of this Article shall be extended by an additional period of one year, where the marketing authorisation holder obtains, during the data protection period referred to in Article 81, an authorisation for an additional therapeutic indication, provided that significant clinical benefit in comparison with existing therapies has been demonstrated by the marketing authorisation holder with supporting data. That extension may only be granted once. [Am. 196]

Added:3. By way of derogation from paragraph 1, the marketing authorisation holder concerned may grant the marketing authorisation applicant for another marketing authorisation a letter of access to its data submitted under Annex I, as referred to in Article 14.

Added:4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant Member State authority in the Union under conditions laid down in Union law and in compliance with international agreements to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licence requires, and during the duration period of the compulsory licence in the Member State(s) where the compulsory license has been granted. [Am. 197]

Added:4a. The marketing authorisation holder for the medicinal product for which a compulsory licence has been granted shall be informed of the decision without delay. [Am. 198]

Added:5. The data protection period set out to in paragraph 1 shall also apply in Member States where the medicinal product is not authorised or is no longer authorised.

Added:Article 81 Regulatory data protection periods

Added:1. The regulatory data protection period shall be sixseven years and six months from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union. [Am. 199]

Added:2. Subject to a scientific evaluation by the relevant competent authority, the data protection period referred to in paragraph 1 shall be prolonged by:

Added:(a) 24 months, where the marketing authorisation holder demonstrates that the conditions referred to in Article 82(1) are fulfilled within two years, from the date when the marketing authorisation was granted or, within three years from that date for any of the following entities:

Added:(i) SMEs within the meaning of Commission Recommendation 2003/361/EC;

Added:(ii) entities not engaged in an economic activity (‘not-for-profit entity’); and

Added:(iii) undertakings that, by the time of granting of a marketing authorisation, have received not more than five centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. [Am. 200]

Added:(b) six12 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83; [Am. 201]

Added:(c) six months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency;

Added:(ca) six months, where the marketing authorisation holder demonstrates that a significant share of research and development, including preclinical and clinical, related to the medicinal product has been done within the Union and at least in part in collaboration with public entities, including university hospital institutes, centres of excellence or bioclusters located in the Union. [Am. 202]

Added:(d) 12 months, where the marketing authorisation holder obtains, during the data protection period, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies. [Am. 203]

Added:In the case of a conditional marketing authorisation granted in accordance with Article 19 of [revised Regulation (EC) No 726/2004] the prolongation referred to in the first subparagraph, point (b), shall only apply if, within four years of the granting of the conditional marketing authorisation, the medicinal product has been granted a marketing authorisation in accordance with Article 19(7) of [revised Regulation (EC) No 726/2004.

Added:The prolongation referred to in the first subparagraph, point (d), may only be granted once. [Am. 204]

Added:By ... [12 months from the date of entry into force of this Directive], the Commission shall adopt delegated acts in accordance with Article 215 to supplement this Directive by setting out the procedural aspects and criteria related to the first subparagraph, point (ca), of this paragraph. [Am. 205]

Added:3. The Agency shall set the scientific guidelines referred to in paragraph 2, point (c), on criteria for proposing a comparator for a clinical trial, taking into account the results of the consultation of the Commission and the authorities or bodies involved in the mechanism of consultation referred to in Article 162 of [revised Regulation (EC) No 726/2004].