36 Amendments of Marisa MATIAS related to 2008/0261(COD)
Amendment 42 #
Proposal for a directive – amending act
Citation 1
Citation 1
Having regard to the Treaty establishingon the Functioning of the European CommunityUnion, and in particular Article 95s 114 and 168 thereof,
Amendment 43 #
Proposal for a directive – amending act
Recital 4 b (new)
Recital 4 b (new)
(4b) The new draft Convention of the Council of Europe on counterfeiting of medicinal products and similar crimes involving threats to public health, which is expected to be open for signature in 2010, should be supported by the Commission and the Member States.
Amendment 44 #
Proposal for a directive – amending act
Recital 4 c (new)
Recital 4 c (new)
(4c) A considerable number of medicines purchased over the internet come from sites that conceal their actual physical address. Therefore, a distinction should be made between legitimate mail-order or internet pharmacies and the illegal supply chain through non-controlled internet purchasing. Member States should ensure that the internet sale of medicinal products is continuously monitored by designated bodies.
Amendment 45 #
Proposal for a directive – amending act
Recital 4 d (new)
Recital 4 d (new)
(4d) European citizens should be made aware of the danger to their health from ordering products from non-controlled internet websites or from the illegal supply chain. The Commission together with the Member States and in cooperation with the patients' and consumers' organisations should adopt measures to increase awareness among the general public on the risks related to purchasing medicinal products on the internet. Public awareness campaigns should inform citizens whether their internet pharmacy is officially registered and controlled by public authorities.
Amendment 51 #
Proposal for a directive – amending act
Citation 1
Citation 1
Having regard to the Treaty establishingon the Functioning of the European CommunityUnion, and in particular Article 95s 114 and 168 thereof,
Amendment 56 #
Proposal for a directive – amending act
Recital 4 a (new)
Recital 4 a (new)
(4a) This Directive is to apply without prejudice to Directive 95/46/EC and should retain clear and effective safeguards whenever personal data is processed.
Amendment 62 #
Proposal for a directive – amending act
Recital 5
Recital 5
(5) Today’s distribution network for medicinal products is increasingly complex and involves many players which are not necessarily wholesale distributors as defined in Directive 2001/83/EC. In order to ensure reliability in the distribution chain, pharmaceutical legislation should address all actors in the distribution chain: this includes not only distributors who procure, hold, store and supply products, but also persons who are involved in transactions without handling the products, such as traders or brokers. They should be submitted to proportionate rules in order to exclude, by all practical means, the possibility that medicinal products which are falsified in relation to their identity, history or source to enter the legal supply chain in the Community.
Amendment 81 #
Proposal for a directive – amending act
Recital 7 a (new)
Recital 7 a (new)
(7a) When removing, replacing or covering the safety feature, the new safety features will be considered equivalent to the original safety features when they offer the same level of efficiency for ascertaining identification, authentication, traceability and absence of tampering, as well as the same level of technical difficulty for duplication.
Amendment 91 #
Proposal for a directive – amending act
Recital 8
Recital 8
(8) Any actor in the supply chain who labels and packages medicinal products, or makes changes to the labelling or packaging, has to be a holder of a manufacturing authorization. In order for the safety features to be effective, the manufacturing authorization holder should only be permitted to remove, replace or cover these features under strict conditions.
Amendment 104 #
Proposal for a directive – amending act
Recital 13 a (new)
Recital 13 a (new)
Amendment 106 #
Proposal for a directive – amending act
Recital 14
Recital 14
(14) In order to facilitate enforcement and control of Community rules relating to active substances used as starting material, the manufacturers or, importers or distributors of those substances should notify their activity.
Amendment 107 #
Proposal for a directive – amending act
Article 1 – point 14 a (new)
Article 1 – point 14 a (new)
Directive 2001/83/EC
Title VII a (new) – Article 85 c (new)
Title VII a (new) – Article 85 c (new)
Amendment 108 #
Proposal for a directive – amending act
Recital 15
Recital 15
(15) To ensure a similar level of protection of human health throughout the Community, and to avoid distortions in the internal market, the harmonised principles and guidelines for inspections of holders of manufacturing and wholesaler authorisations of medicinal products as well as manufacturers and distributors of active substances should be strengthened. This should also help to ensure the functioning of existing mutual recognition agreements which rely on efficient and comparable inspection and enforcement throughout the Community.
Amendment 109 #
Proposal for a directive – amending act
Recital 15 a (new)
Recital 15 a (new)
(15a) Member States should impose effective sanctions for acts related to falsified medicines. Those sanctions should at least be equivalent to those typically applied for illegal acts related to narcotics. The Commission may issue general guidelines for such an effective criminal sanctions regime. Specific provisions should be included in Directive 2001/83/EC for enforcing the new safety feature requirements. In cases of authorised or otherwise legitimate medicinal products with quality defects due to mistakes in the manufacturing or subsequent handling, the relevant Union or national legislation shall apply.
Amendment 111 #
Proposal for a directive – amending act
Recital 16
Recital 16
(16) The measures necessary for the implementation of this Directive should be adoptedIn accordance with Article 291 TFEU, rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers shall be laid down in advance by a Regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new Regulation, given the necessity of adopting and implementing this Directive as soon as possible, control by Member States should be carried out in accordance with the provisions of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred byon the Commission, insofar as those provisions remain compatible with the amended Treaties. References to those provisions should nevertheless be replaced with references to the rules and principles set out in the new Regulation as soon as that Regulation enters into force.
Amendment 113 #
Proposal for a directive – amending act
Recital 17
Recital 17
(17) In particular the Commission should be empowered to adopt measures regardingdelegated acts in accordance with Article 290 TFEU in respect of safety features that shall appear on the packaging of medicinal products subject to medical prescription and to adopt detailed rules for medicinal products introduced without being placed on the market. Since those measures are of general scope and are designed to amend non-essential elements by supplementing it, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
Amendment 113 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118 c a (new)
Article 118 c a (new)
Article 118ca The Commission and the Member States shall cooperate closely with the Council of Europe on the establishment of a European Convention on the suppression of the falsification of medicinal products and trafficking in falsified medicines. The Convention covers the civil and criminal law aspects of falsification and trafficking of falsified medicinal products.
Amendment 157 #
Proposal for a directive – amending act
Article 1 – point -1 a (new)
Article 1 – point -1 a (new)
Directive 2001/83/EC
Article 1 – point 2 b (new)
Article 1 – point 2 b (new)
(-1a) In Article 1, the following point 2b is inserted after point 2a: 2b. Active substance used as starting material: Any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.
Amendment 170 #
Proposal for a directive – amending act
Article 1 – point 3 – point a
Article 1 – point 3 – point a
Directive 2001/83/EC
Article 46 – point f - subparagraph 1
Article 46 – point f - subparagraph 1
(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances and excipients, which have been manufactured and distributed in accordance with the detailed guidelines on good manufacturing and distribution practices for starting materials. To this end, the holder of the manufacturing authorization shall verify compliance of the active substances manufactureand the excipients manufacturer and distributor with good manufacturing practices by himself or through a body accredited for this purpose by the competent authority of a Member State.
Amendment 177 #
Proposal for a directive – amending act
Article 1 – point 3 – point a a (new)
Article 1 – point 3 – point a a (new)
Directive 2001/83/EC
Article 46 – point f – subparagraph 2
Article 46 – point f – subparagraph 2
(aa) The second subparagraph of point (f) is replaced by the following: The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c, a list of certain categories of excipients identified on a risk-based approach taking into account their source and their intended use. For these categories of excipients, the manufacturer shall apply the appropriate good manufacturing practices on the basis of a formalised risk assessment in accordance with the applicable guidelines referred to in the second paragraph of Article 47, taking into account other suitable quality system requirements, and document this.
Amendment 188 #
Proposal for a directive – amending act
Article 1 – point 4
Article 1 – point 4
Directive 2001/83/EC
Article 46b – paragraph 1
Article 46b – paragraph 1
(1) Member States shall take appropriate measures to ensure that the manufacture and distribution on their territory of active substances used as starting material, including active substances that are intended for export, complies with good manufacturing practices for active substances.
Amendment 193 #
Proposal for a directive – amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 47 – paragraph 3
Article 47 – paragraph 3
The Commission shall adopt, by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c, the principles of good manufacturing and distribution practices for active substances used as starting materials and excipients referred to in point (f) of Article 46 and in Article 46b shall be adopted in the form of detailed guidelines.’criteria.
Amendment 199 #
Proposal for a directive – amending act
Article 1 - point 7
Article 1 - point 7
Directive 2001/83/EC
Article 52b
Article 52b
(1) Notwithstanding Article 2(1), and without prejudice to Title VII, Member States shall entake the necessary measures thao prevent medicinal products not intended to be placed on the market are notfrom being introduced into the CommunityUnion if there are reasons to believe that these products claim aare falsified identity, history or source. (2) The Commission shall adopt the necessary measures for the implementa. (2) In order to establish the necessary measures referred to in paragraph (1), the Commission shall adopt by means of delegated acts in accordance with Article 121a and subject to the conditions of paragraph 1. Those measures, designed to amend non- essential elements of this Directive by supplementing it, shall bArticles 121b and 121c: - The criteria to be considered and the verifications to be made by the national authorities when assessing a medicinal product intended for introduction into the Union in terms of identity, history or source. - The documentation that is to accompany the medicinal product in order to facilitate enforcement, without prejudice to the applicable adopted in accordance with the regulatory procedure with scrutiny referred to in Article 121(2a).’ cumentation requirements in accordance with customs legislation. - The minimum extent of cooperation and the mechanisms between customs authorities and competent authorities for medicinal products. This shall at least include risk management concepts and triggers for inspections.
Amendment 249 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 1
Article 54a – paragraph 4 – subparagraph 1
Amendment 252 #
Proposal for a directive – amending act
Article 1 - point 9
Article 1 - point 9
Directive 2001/83/EC
Article 54a – paragraph 4 – subparagraph 2
Article 54a – paragraph 4 – subparagraph 2
Amendment 299 #
Proposal for a directive – amending act
Article 1 – point 11 a (new)
Article 1 – point 11 a (new)
Directive 2001/83/EC
Article 76 – paragraph 3
Article 76 – paragraph 3
(11a) In Article 76, paragraph 3 is replaced by the following: 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, including fees payable to the competent authorities for the examination of the notification.
Amendment 300 #
Proposal for a directive – amending act
Article 1 – point 11 a (new)
Article 1 – point 11 a (new)
Directive 2001/83/EC
Article 76 – paragraph 3 a (new)
Article 76 – paragraph 3 a (new)
(11a) In Article 76, the following paragraph is added: 3a. In the case of products which have been granted an authorisation pursuant to Regulation (EC) No 726/2004, the distributor shall submit the notification in accordance with paragraph 3 to the marketing authorisation holder and the Agency. The notification shall be accompanied by a fee payable to the Agency for checking that the conditions laid down in Union legislation are complied with.
Amendment 332 #
Proposal for a directive – amending act
Article 1 – point 14 a (new)
Article 1 – point 14 a (new)
Directive 2001/83/EC
Title VII a (new) – Article 85 c (new)
Title VII a (new) – Article 85 c (new)
14a) The following Title VIIa and Article 85c are inserted after Article 85b: 'TITLE VIIa INTERNET SALES Article 85c 1. The Commission shall, by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c, adopt an EU logo for the front page of internet pharmacy sites, helping the public to identify whether a website offering to sell medicinal products is connected to a registered pharmacy. The logo shall be linked to a central website at Member State level, to be established by the Member State, that allows the visitor to check the authenticity of the logo and that provides background information on the risks related to buying medicinal products on the internet. 2. Member States shall take the appropriate measures to ensure that all registered pharmacy internet sites linked to pharmacies within their territory display the EU logo referred to in paragraph 1 and to prevent non-registered pharmacy internet sites from using the logo and linking to the central website referred to in paragraph 1.'
Amendment 336 #
Proposal for a directive – amending act
Article 1 – point 14 b (new)
Article 1 – point 14 b (new)
Directive 2001/83/EC
Article 85 d (new)
Article 85 d (new)
(14b) The following Article 85d is inserted: 'Article 85d 1. The Commission shall, by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121b and 121c, adopt measures to increase awareness among the general public on the risks related to purchasing medicinal products on the internet, which may include: - warnings appearing on top of the internet page in search engines in the event of a search for medicinal products on the internet; - general information campaigns, in cooperation with the Member States; - easily accessible lists of accredited e- pharmacies'
Amendment 344 #
Proposal for a directive – amending act
Article 1 – point 15 – point a a (new)
Article 1 – point 15 – point a a (new)
Directive 2001/83/EC
Article 111 – paragraph 1 – subparagraph 2
Article 111 – paragraph 1 – subparagraph 2
(aa) Article 111(1), subparagraph 2 is replaced by the following: The competent authority shall also carry out unannounced inspections at the premises of manufacturers, distributors or importers of active substances used as starting materials, at the premises of marketing authorisation holders and at the premises of manufacturers or importers or distributors of excipients, whenever it considers that there are grounds for suspecting non-compliance with the principles and guidelines of good manufacturing practice referred to in Article 47. These inspections may also be carried out at the request of a Member State, the Commission or the Agency. The competent authority shall also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials and of excipients based in third countries.
Amendment 353 #
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111b - paragraph 1 - introductory part
Article 111b - paragraph 1 - introductory part
Amendment 356 #
Proposal for a directive – amending act
Article 1 – point 16
Article 1 – point 16
Directive 2001/83/EC
Article 111b - paragraph 2
Article 111b - paragraph 2
(2 ) The Commission, in accordance with the procedure set out in shall, by means of delegated acts in accordance with Article 121a and subject to the conditions of Articles 121(2), shall adopt guidelinesb and 121c, adopt criteria defining in detail the requirements set out in points (a) to (d) of paragraph 1.
Amendment 361 #
Proposal for a directive – amending act
Article 1 – point 17
Article 1 – point 17
Directive 2001/83/EC
Article 118b a (new)
Article 118b a (new)
Article 118ba The penalties referred to in Article 118b should be equivalent to those typically applied for illegal acts related to narcotics and should be equivalent in all Member States in accordance with the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health.
Amendment 367 #
Proposal for a directive – amending act
Article 1 – point 17 a (new)
Article 1 – point 17 a (new)
Directive 2001/83/EC
Article 121a
Article 121a
(17a) The following Article 121a is inserted: Article 121a Exercise of the delegation (1)The powers to adopt the delegated acts referred to in Article 52b shall be conferred on the Commission for an indeterminate period of time. (2) As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. (3) The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 121b and 121c.
Amendment 368 #
Proposal for a directive – amending act
Article 1 – point 17 a (new)
Article 1 – point 17 a (new)
Directive 2001/83/EC
Article 121b
Article 121b
(17a) The following Article 121b is inserted: Article 121b Revocation of the delegation 1. The delegation of power referred to in Article 52b may be revoked by the European Parliament or by the Council. 2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.
Amendment 369 #
Proposal for a directive – amending act
Article 1 – point 17 a (new)
Article 1 – point 17 a (new)
Directive 2001/83/EC
Article 121c
Article 121c
(17a) The following Article 121c is inserted: Article 121c Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by two months. 2. If neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and enter into force at the date stated therein. 3. If the European Parliament or the Council objects to the adopted delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.