What changed between the plenary report and the adopted text

Added:(137) The dissemination of information which encourages the purchase of medicinal products should be considered within the concept of advertising of medicinal products, even where that information does not refer to a specific medicinal product, but to unspecified medicinal products.

Removed:Article 57 – paragraph 2 – point a – point iii a (new): (iiia) where relevant, any independent legal entity from which it obtained a licence in relation to, or acquired the medicinal product in its previous phases of development, and at which stage of the research and development process. The marketing authorisation holder shall, to the extent possible, include in the report information on funding received as referred to paragraph 1 specific to the relevant medicinal product.

Added:(138) Advertising of medicinal products should be subject to strict conditions and effective, adequate monitoring. Reference in this regard should be made to the monitoring mechanisms set up by Directive 2006/114/EC.

Removed:Article 57 – paragraph 6: 6. The Commission shall adopt implementing acts to lay down the principles and format for the information to be reported pursuant to paragraph 2, by [12 months from the date of entry into force of this Directive]. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

Added:(138a) Because of the global reach of social media, patients and consumers are increasingly exposed to the promotional practices of using celebrities to advertise medicinal products. The Commission should assess the exposure and impact of pharmaceutical advertising and promotions online, and adopt specific rules to regulate such advertising and promotional practices. [Am. 75]

Removed:Article 57 – paragraph 6 a (new): 6a. The Agency shall provide on its website the links to the information communicated to the Agency in accordance with paragraphs 2 and 3, sorted, where relevant, by medicinal product and by Member State.

Added:(139) Medical sales representatives have an important role in the promotion of medicinal products. Therefore, certain obligations should be imposed upon them, in particular the obligation to supply the person visited with a summary of product characteristics.

Removed:Article 58 a (new): Article58a / Obligation to submit an application for pricing and reimbursement in all Member States / 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, in good faith and within the limits of its responsibilities, submit an application for pricing and reimbursement for the medicinal product and, where relevant, negotiate. In the case of a positive decision to permit the marketing of the medicinal product in accordance with Directive 89/105/EEC, the obligation in Article 56(3) of this Directive to ensure appropriate and continued supply to cover the needs of patients in that Member State shall apply. The application for pricing and reimbursement for the medicinal product shall be submitted no later than 12 months from the date when the Member State made its request, or within 24 months from that date for any of the following entities: / (i) SMEs; / (ii) entities not engaged in an economic activity (‘not-for-profit entity’); and / (iii) undertakings that, by the time of granting the 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. / The deadlines set out in the first subparagraph of this paragraph shall be prolonged by six months following the notification of the m…

Added:(139a) Even minimal inducement can result in biased decisions with regard to prescription behaviour by physicians. Therefore, to avoid conflict of interest, Member States should maintain a transparency register of transfer of value regarding advertising activities which target persons qualified to prescribe medicinal products. The Commission should establish a web portal to list all national registers of transfers of value to persons qualified to prescribe medicinal products. [Am. 76]

Removed:Article 58 b (new): Article58b / EU Access to Medicines Notification System / 1. The Commission shall set up and maintain an electronic notification system for the notification of compliance with the obligations set out in Article 58a (the ‘EU Access to Medicines Notification System’). The EU Access to Medicines Notification System shall be interoperable with other relevant Union-wide data repositories for medicinal products. / 2. The marketing authorisation holder shall use the EU Access to Medicines Notification System to notify their compliance with the obligations set out in Article 58a. In the Member States where the marketing authorisation is valid, the national competent authority shall use the EU Access to Medicines Notification System to indicate that the marketing authorisation holder has fulfilled its obligations set out in Article 58a. / 3. By ... [3 years from the date of entry into force of this Directive], the Commission shall adopt implementing acts to establish technical and organisational requirements. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). / 4. By ... [5 years from the date of entry into force of this Directive], the Commission shall assess the feasibility of extending the EU Access to Medicines Notification System to other areas of the process for pricing of medicinal products as set out in Directive 89/105/EEC and, if appropriate, adopt implementing acts to establish this extended system. Those imp…

Added:(140) Innovative, ‘combination medicinal products’ and other developed medicinal products are complex in regards to their composition and administration. Therefore, in addition to persons qualified to prescribe medicinal products, also persons qualified to administer medicinal products need to be familiar with all characteristics of those medicinal products, especially with safe administration and use, including the comprehensive instructions to the patients. For that purpose information about medicinal products subject to medical prescription is also clearly allowed to persons qualified to administer them.

Removed:Article 63 – paragraph 3: 3. Member States may decide that for individual medicinal products, categories of medicinal products or for all medicinal products, the package leaflet shall be made available both in paper format and electronically or electronically only. In the latter case, the decision shall be made only following a consultation of patients, carers and other relevant stakeholders. In the absence of such specific rules in a Member State, a package leaflet shall be made available electronically and be included in paper format in the packaging of a medicinal product. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients as well as written and designed in a clear and understandable way.

Added:(141) Persons qualified to prescribe, administer or supply medicinal products should have access to a neutral, objective source of information about products available on the market. Whereas it is nevertheless for the Member States to take all measures necessary to this end, in the light of their own particular situation.

Removed:Article 63 – paragraph 3 a (new): 3a. If a Member State has decided that the package leaflet is only to be made available electronically, patients shall be made aware of their right to a printed copy of the package leaflet.

Added:(142) In order to ensure that information on the use of the medicinal products in children are appropriately taken into account at the moment of marketing authorisation, it is therefore necessary to introduce a requirement for new medicinal products or when developing paediatric indications of already authorised products covered by a patent or a supplementary protection certificate, to present either the results of studies in the paediatric population in accordance with an agreed paediatric investigation plan or proof of having obtained a waiver or deferral, at the time of filing a marketing authorisation application or an application for a new therapeutic indication, new pharmaceutical form or new route of administration. In order to ensure that the data supporting the marketing authorisation concerning the use of a product in children, the competent authorities responsible for the authorisation of a medicinal product should check compliance with the agreed paediatric investigation plan and any waivers and deferrals at the validation step for marketing authorisation applications.

Removed:Article 63 – paragraph 3 b (new): 3b. If a Member State decides that the package leaflet shall be made available electronically, a paper package leaflet in addition to the electronic format may be made available on a voluntary basis by the marketing authorisation holder in addition to the electronic package leaflet.

Added:(143) To provide healthcare professionals and patients with information on the safe and effective use of medicinal products in the paediatric population, the results of the studies conducted in accordance with a paediatric investigation plan, independently from the fact that they support or not the use of the medicinal product in children, appropriate information should be included in the summary of product characteristics and, if appropriate, in the package leaflet. Information on waivers should also be included in product information. When all the measures in the paediatric investigation plan have been complied with, that fact should be recorded in the marketing authorisation, and that should then be the basis upon which companies can obtain rewards.

Removed:Article 63 – paragraph 4 a (new): 4a. By way of derogation from paragraph 3, where the medicinal product is intended for dispensation and administration by a qualified healthcare professionals rather than for self-administration by the patient, the package leaflet may be made available only electronically.

Added:(144) Relevant data and information collected through clinical studies conducted before the introduction in the Union of a paediatric medicines Regulation and received by the competent authorities should be assessed without undue delay and taken into consideration for eventual variation of existing marketing authorisations.

Removed:Article 63 – paragraph 5: deleted

Added:(145) In order to ensure uniform conditions for the implementation of this RegulationDirective, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council. [Am. 77]

Removed:Article 63 – paragraph 6: 6. By ... [12 months from the date of entry into force of this Directive], the Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies.

Added:(146) Due to the need to reduce overall approval times for medicinal products, the time between the opinion of the Committee for Medicinal Products for Human Use (CHMP) and the final decision on any Commission Decision concerning national marketing authorisations, in particular for referrals, should be reduced to, in principle, 46 days.

Removed:Article 63 – paragraph 6 a (new): 6a. The Agency shall make available a system to accommodate the electronic product information after consultation with Member States and the relevant stakeholders. The system shall be available at the latest by [24 months from the date of entry into force of this Directive].

Added:(147) On the basis of the opinion of the Agency, the Commission should adopt a decision on the referral by means of implementing acts. In justified cases, the Commission may return the opinion for further examination or deviate in its decision from the opinion of the Agency. Taking into account the need to make medicinal products swiftly available to patients, it should be acknowledged that the chairperson of the Standing Committee for Medicines for Human Use will use the available mechanisms under Regulation 182/2011 and notably the possibility to obtain the committees opinion in written procedure and within expeditious deadlines which, in principle, will not exceed 10 calendar days.

Removed:Article 63 – paragraph 7: 7. When accessing the package leaflet electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data in accordance with Regulation (EU) 2016/679 and Directive 2002/58/EC and shall not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes including for advertising or marketing activities.

Added:(148) The Commission should be empowered to adopt any necessary changes to Annex II in order to take into account scientific and technical progress.

Removed:Article 64 – paragraph 3: 3. Following a consultation with target patient groups and other relevant stakeholders, the Commission shall adopt guidelines to ensure that the package leaflet is legible, clear and easy to use.

Added:(149) In order to supplement or amend certain non-essential elements of this Directive, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the procedure for examination of application of active substance master file certificate, the publication of such certificates, the procedure for changes to the active substance master file and its certificate, access to the active substance master file and its assessment report; specifying additional quality master files to provide information on a constituent of a medicinal product, the procedure for examination of application of a quality master file certificate or a platform technology master file certificate, the publication of such certificates, the procedure for changes to the quality master file and its certificate, and access to the quality master file and its assessment report; determining the situations in which post-authorisation efficacy studies may be required; specifying the categories of medicinal products to which a marketing authorisation subject to specific obligations could be granted and specifying the procedures and requirements for granting such a marketing authorisation and for its renewal; specifying exemptions to variation and the categories in which variations should be classified and establishing procedures for the examination of applications for variations to the terms of marketing authorisations as well as specifying conditions and procedures for cooperation with third countries and international organisations for examination of applications for such variations. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. [Am. 78]

Removed:Article 66 – paragraph 1: 1. The particulars laid down in Annex IV shall appear on immediate packagings other than those referred to in the paragraphs 2 and 3 and shall allow, at the request of the national competent authorities, single dispensation, particularly in the event of a shortage or major public health issue.

Added:(150) This Directive seeks to enable the right access to preventive healthcare and to benefit from medical treatment under the conditions established by national laws and practices and to ensure a high level of human health protection in the definition and implementation of all the Union’s policies and activities as laid down in Article 35 of the Charter of Fundamental Rights of the European Union.

Removed:Article 66 – paragraph 2 a (new): 2a. Each single dose of the blister pack shall include the following labelling particulars: / (a) the name of the medicinal product followed by its strength and pharmaceutical form; / (b) a data matrix code in which the following information is encoded: (i) the Global Trading Index Number (GTIN) / (ii) the expiry date; / (iii) the batch number.

Added:(151) Since the objectives of this Directive, namely to establish rules on medicinal products ensuring the protection of public health and the environment as well as the functioning of the internal market, cannot be sufficiently achieved by the Member States as national rules would lead to disharmonisation, unequal patient access to medicinal products and barriers to the internal market, but can rather, by reason of its effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.

Removed:Article 67 – paragraph 1 – subparagraph 2: Medicinal products not subject to prescription shall not bear the safety features referred to in Annex IV, unless, by way of exception, they have been listed in accordance with the procedure referred to in paragraph 2, second subparagraph, point (b), or where the marketing authorisation holder chooses to do so voluntarily.

Added:(152) In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified.

Removed:Article 67 – paragraph 7 a (new): 7a. For the purpose of patient safety, Member States may decide that medicinal products imported or distributed in parallel shall be repackaged in new outer packaging.

Added:HAVE ADOPTED THIS DIRECTIVE:

Removed:Article 69 – paragraph 1: 1. The marketing authorisation holder shall ensure availability of educational material to healthcare professionals, regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial-resistant pathogens, that may inform on the use of the antimicrobial. Any informational material shall be compatible with the summary of product characteristics.

Added:Chapter I: Subject matter, scope and definitions

Removed:Article 69 – paragraph 2 – subparagraph 2: Member States shall ensure that the awareness card is made available in paper format or both in paper format and electronically in the packaging of an antimicrobial.

Added:Article 1 Subject matter and scope

Removed:Article 69 – paragraph 3 – subparagraph 1 a (new): Members States shall introduce appropriate disposal systems for antimicrobials in the community setting, and inform the general public on the correct disposal methods for antimicrobial.

Added:1. This Directive lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of medicinal products for human use.

Removed:Article 69 – paragraph 3 a (new): 3a. The Commission may adopt implementing acts laying down further standards for the awareness card after consulting the Agency. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

Added:2. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States. [Am. 79]

Removed:Article 73 – paragraph 1: 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 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.

Added:3. In addition to the products referred to in paragraph 2, Chapter XI shall also apply to starting materials, active substances, excipients and intermediate products.

Removed:Article 74 – paragraph 4: 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. / 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:4. In cases where, taking into account all its characteristics, a product falls within the definition of a ‘medicinal product’ and within the definition of a product covered by other Union law and there is a conflict between this Directive and other Union law, the provisions of this Directive shall prevail.

Removed:Article 77 – paragraph 1 – point a a (new): (aa) the wording on prudent use and safe disposal of antimicrobials;

Added:In cases where, taking into account all its characteristics, questions arise as to the regulatory status of a substance or a product, the competent authority or, in the case of a centralised marketing authorisation, the Agency shall consult other relevant advisory and regulatory bodies with a view to reaching a decision on the regulatory status of the substance or a product concerned. In any decision on such question, the competent authority or the Agency shall make publicly available the views of other authorities or bodies consulted. [Am. 80]

Removed:Article 80 – paragraph 2 a (new): 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.

Added:5. The Directive shall not apply to:

Removed:Article 80 – paragraph 4: 4. By way of derogation from 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, 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.

Added:(a) medicinal products prepared in a pharmacy in accordance with a medical prescription for an individual patient (‘magistral formula’);

Removed:Article 80 – paragraph 4 a (new): 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.

Added:(b) medicinal product prepared in a pharmacy in accordance with a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question or to another pharmacy which intends to supply the medicinal product directly to the patient (‘officinal formula’); [Am. 81]

Removed:Article 81 – paragraph 1: 1. The regulatory data protection period shall be seven 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.

Added:(c) investigational medicinal product as defined in Article 2, paragraph 5, of Regulation (EU) No 536/2014.

Removed:Article 81 – paragraph 2 – subparagraph 1 – point a: deleted / (deleted) / (deleted) / (deleted)