Changes from plenary report to adopted text

Added5. The Standing Committee on Medicinal Products for Human Use shall ensure that its rules of procedure are adapted to the need to make medicinal products swiftly available to patients and take account of the tasks incumbent upon it under Chapter III and the procedure set out in Article 42.

AddedArticle 215 Exercise of the delegations

Added1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

Added2. The power to adopt delegated acts referred to in Articles 4(2), 24(5), 25(9), 26(3), 28, paragraphs 2 and 3, 27(3), 63(5), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 210(4) and 213 shall be conferred on the Commission for a period of five years from [OP please insert the date of the entry into force of this Directive]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

AddedThe power to adopt delegated acts referred to in Article 210, paragraphs 3 and 5, shall be conferred on the Commission for an indeterminate period of time from [OP please insert the date = the date of the entry into force of this Directive].

Added3. The delegation of power referred to in Articles 4(2), 24(5), 25(9), 26(3), 27(3), 28, paragraphs 2 and 3, 63(5), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 210(4) and 213 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Added4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

Added5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

Added6. A delegated act adopted pursuant to Articles 6(2), 26(3), 24(5), 28, paragraphs 2 and 3, 27(3), 63(5), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 210(4) and 213 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

AddedArticle 216 Report

Added1. By [OP please insert the date = 10 years following 18 months after the date of entering into force of this Directive], the Commission shall present a report to the European Parliament and the Council on the application of this Directive, including an assessment of the fulfilment of its objectives and the resources required to implement it, including regarding the revised framework for regulatory data protection periods. [Am. 325]

Added1a. By ...[2 years from the date of entry into force of this Directive], the Commission shall submit a report to the European Parliament and the Council evaluating the appropriateness of the framework of homeopathic products, in particular aspects of public health and patient protection. The report shall, where appropriate, be accompanied by a legislative proposal. [Am. 326]

AddedArticle 216a Fostering research on, and innovation and production of, medicinal products in the Union

Added1. The Commission shall establish a strategy on fostering research on, and innovation and production of, medicinal products in the Union, based on the results published in the report provided for in paragraph 2. Member States shall be encouraged to participate in that strategy.

Added2. By... [two years from the date of entry into force of this Directive], the Commission shall present an impact assessment evaluating potential measures to be implemented at Union level and at a Member State level to foster research on, and innovation and production of, critical medicinal products in the Union. That report shall evaluate the effect of measures such as:

Added(a) funding and push and pull incentives directed to foster research and innovation in the Union, including public and private funding for preclinical and clinical research and innovation;

Added(b) public-private partnerships in research and innovation;

Added(c) regulatory support for public research and innovation entities;

Added(d) incentives for production of critical medicinal products within the Union.

AddedAny proposed measures shall be in line with the development of the strategic autonomy of the Union regarding medicinal products. [Am. 327]

AddedArticle 217 Repeals

Added1. Directive 2001/83/EC is repealed with effect from [OP please insert the date = 18 months after the date of entering into force of this Directive].

Added2. Directive 2009/35/EC is repealed with effect from [OP please insert the date = 18 months after the date of entering into force of this Directive].

Added3. References to the repealed Directives 2001/83/EC and 2009/35/EC shall be construed as references to this Directive. References to the repealed Directive 2001/83/EC shall be read in accordance with the correlation table in Annex VIII.

AddedArticle 218 Transitional provisions

Added1. The procedures concerning the applications for marketing authorisations for medicinal products validated in accordance with Article 19 of Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive] and that were pending on [OP please insert the date = the day before 18 months after the date of entering into force of this Directive] shall be completed in accordance with Article 29.

Added2. Procedures initiated on the basis of Articles 29, 30, 31, and 107i of Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive] and that were pending on [OP please insert the date = the day before 18 months after the date of entering into force of this Directive] shall be completed in accordance with Articles 32 to 34 or Article 107k, as appropriate, of that Directive as applicable on [OP please insert the date = the day before 18 months after the date of entering into force of this Directive].

Added3. This Directive shall also apply to medicinal products authorised in accordance with Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive].

AddedThis Directive shall also apply to registrations of homeopathic medicinal products and traditional herbal medicinal products carried out in accordance with Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive].

Added4. By way of derogation from Chapter VI, the medicinal products placed on the market in accordance with Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive] may continue to be made available on the market until [OP please insert the date = five years after 18 months after the date of entering into force of this Directive], provided that they comply with the provision on labelling and package leaflet set out in Title V of Directive 2001/83/EC as applicable on [OP please insert the date = the day before 18 months after the date of entering into force of this Directive].

Added5. By way of derogation from Article 81, reference medicinal products for which the application for marketing authorisation has been submitted before [OP please insert the date = 18 months after the date of entering into force of this Directive] shall be subject to the provisions on data protection periods set out in Article 10 of Directive 2001/83/EC as applicable on [OP please insert the date = 18 months after the date of entering into force of this Directive] until [OP please insert the date = 18 months after the date of entering into force of this Directive].

Added6. By way of derogation from paragraph 3, the reporting obligations as referred to in Article 57, shall not apply with regards to medicinal products authorised in accordance with Directive 2001/83/EC before [OP please insert the date = 18 months after the date of entering into force of this Directive].

AddedArticle 219 Transposition

Added1. Member States shall bring into force the laws, regulations and administrative provisions to comply with this Directive by [18 months after the date of entering into force of this Directive]. They shall immediately communicate the text of those measures to the Commission.

Added2. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directives repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated.

Added3. Member States shall communicate to the Commission the text of the main measures of national law that they adopt in the field covered by this Directive.

AddedArticle 220 Entry into force

AddedThis Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

AddedArticle 221 Addressees

AddedThis Directive is addressed to the Member States.

AddedDone at …,

AddedFor the European Parliament For the Council

AddedThe President The President

AddedAnnex I

AddedINFORMATION REFERRED TO IN THE APPLICATION

Added(1) Name or corporate name and permanent address of the applicant and, where applicable, of the manufacturer.

Added(2) Name of the medicinal product.

Added(3) Qualitative and quantitative particulars of all the constituents of the medicinal product, including the reference to its international non-proprietary name (INN) recommended by the World Health Organization, where an INN for the medicinal product exists, or a reference to the relevant chemical name.

Added(4) An environmental risk assessment (ERA) in accordance with the requirements laid down in Articles 22 and 23.

Added(5) For medicinal product for human use containing or consisting of genetically modified organisms, an environmental risk assessment identifying and characterising possible hazards for human health, animals and the environment. The assessment shall be conducted in accordance with the elements described in Article 8 of [revised Regulation (EC) No 726/2004] and the requirements of Annex II to this Directive, based on the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council1 taking into account the specificities of medicinal products.

Added(6) Description of the manufacturing method.

Added(7) Therapeutic indications, contra-indications and adverse reactions.

Added(8) Posology, pharmaceutical form, method and route of administration and expected shelf life.

Added(9) Reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and for the disposal of waste products, together with an indication of potential risks presented by the medicinal product for the environment.

Added(10) Description of the control methods employed by the manufacturer.

Added(11) A written confirmation that the manufacturer of the medicinal product has verified compliance of the manufacturer of the active substance with principles of good manufacturing practice by conducting audits, in accordance with Article 160. The written confirmation shall contain a reference to the date of the audit and a declaration that the outcome of the audit confirms that the manufacturing complies with the principles of good manufacturing practice.

Added(12) Results of:

Added(a) pharmaceutical (physico-chemical, biological or micro biological) tests,

Added(b) non-clinical (toxicological and pharmacological) tests,

Added(c) clinical trials.