Changes from plenary report to adopted text

AddedThe batches of medicinal products that have undergone the controls referred to in the first subparagraph, point (b), in a Member State shall be exempt from those controls if they are marketed in another Member State, accompanied by the control reports signed by the qualified person.

Added2. In the case of medicinal products imported from a third country, where appropriate arrangements have been made by the Union with the exporting country to ensure that the manufacturer applies standards of good manufacturing practice at least equivalent to those laid down by the Union, and to ensure that the controls referred to in paragraph 1, first subparagraph, point (b), have been carried out in the exporting country, the qualified person may be relieved of responsibility for carrying out those controls.

Added3. In all cases and particularly where the medicinal products are released for sale, the qualified person shall certify in a register or equivalent format provided for that purpose, that each production batch satisfies the provisions of this Article; that register or equivalent format shall be kept up to date during the time when operations are carried out and shall remain at the disposal of the official representatives of the competent authority of the Member State for the period specified in the provisions of the Member State concerned and in any event for at least five years.

Added4. For the purposes of Article 151(3), the qualified person shall, in addition:

Added(a) supervise that the manufacturing or testing activities carried out at the decentralised sites comply with principles of relevant good manufacturing practices referred to in Article 160 and conform to the marketing authorisation;

Added(b) provide a written confirmation as referred to in Article 144(2), second subparagraph;

Added(c) notify to the competent authority of the Member State where the decentralised site is established, an inventory of the changes that have taken place as regards the information provided in the registration form submitted pursuant to Article 148(5).

AddedAny changes that may have an impact on the quality or safety of the medicinal products that are manufactured or tested at the decentralised site must be notified immediately.

AddedThe Commission is empowered to adopt a delegated act in accordance with Article 215 to supplement the first subparagraph, point (c), specifying the notification made by the qualified person.

AddedArticle 154 Professional code of conduct

Added1. Member States shall ensure that the duties of qualified persons referred to in Article 151 are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct.

Added2. Member States may provide for the temporary suspension of a qualified person referred to in Article 151 upon the commencement of administrative or disciplinary procedures against that qualified person for failure to fulfil its duties set out in Article 153.

AddedArticle 155 Certificate for export of a medicinal product

Added1. At the request of the manufacturer, the exporter or the competent authorities of an importing third country, Member States shall certify that a manufacturer of medicinal products is in possession of a manufacturing authorisation. When issuing such certificates Member States shall:

Added(a) comply with the prevailing administrative arrangements of the World Health Organization;

Added(b) for medicinal products intended for export that are already authorised in their territory, supply the summary of product characteristics as approved by them in accordance with Article 43.

Added2. When the manufacturer is not in possession of a marketing authorisation it shall provide the competent authorities responsible for issuing the certificate referred to in paragraph 1, with a declaration explaining why a marketing authorisation is not available.

AddedSection 2 Manufacturing, import and distribution of active substances

AddedArticle 156 Manufacture of active substances

AddedFor the purposes of this Directive, manufacture of active substances used in the manufacturing process of a medicinal product shall include both total and partial manufacture or import of an active substance 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 active substances.

AddedArticle 157 Registration of importers, manufacturers and distributors of active substances

Added1. Importers, manufacturers and distributors of active substances who are established in the Union shall register their activity with the competent authority of the Member State in which they are established.

Added2. The registration form, to be submitted by electronic means, shall include, at least, the following information:

Added(a) name or corporate name and permanent address;

Added(b) the active substances that are to be imported, manufactured or distributed;

Added(c) particulars regarding the premises and the technical equipment for their activity.

Added3. The persons referred to in paragraph 1 shall submit, by electronic means, the registration form to the competent authority of the Member State at least 60 days prior to the intended commencement of their activity.

Added4. The competent authority of the Member State may, based on a risk assessment, decide to carry out an inspection. If the competent authority of the Member State notifies the applicant within 60 days of the receipt of the registration form that an inspection will be carried out, the activity shall not begin before the competent authority of the Member State has notified the applicant that they may commence the activity. If within 60 days of the receipt of the registration form the competent authority of the Member State has not notified the applicant that an inspection will be carried out, the applicant may commence the activity.

Added5. Annually, the persons referred to in paragraph 1 shall communicate, by electronic means, to the competent authority of the Member State an inventory of the changes that have taken place as regards the information provided in the registration form. Any changes that may have an impact on the quality or safety of the active substances that are manufactured, imported or distributed must be notified immediately.

Added6. The competent authority of the Member State shall enter the information provided in accordance with paragraph 2 in the Union database referred to in Article 188(15).

AddedArticle 158 Conditions for importing active substances

Added1. Member States shall take appropriate measures to ensure that the manufacture, import and distribution on their territory of active substances, including active substances that are intended for export, comply with the principles of good manufacturing practice and good distribution practices for active substances specified in the delegated acts adopted in accordance with Article 160.

Added2. Active substances shall only be imported if the following conditions are fulfilled:

Added(a) the active substances have been manufactured in accordance with the principles of good manufacturing practices at least equivalent to those laid down by the Union pursuant to Article160; and

Added(b) the active substances are accompanied by a written confirmation issued by the competent authority of the exporting third country stating that:

Added(i) the principles of good manufacturing practices applicable to the manufacturing site manufacturing the exported active substance are at least equivalent to those laid down by the Union pursuant Article 160;

Added(ii) the manufacturing site concerned is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure a protection of public health at least equivalent to that in the Union; and

Added(iii) in the event of findings relating to non-compliance, information on such findings is supplied by the exporting third country to the Union without undue delay.

Added3. The conditions set out in paragraph 2, point (b), shall not apply if the exporting country is included in the list referred to in Article 159(2).

Added4. The conditions set out in paragraph 2, point (b), may be waived by any competent authority of a Member State for a period not exceeding the validity of the certificate of good manufacturing practice issued in accordance with Article 188(13) where a site manufacturing an active substance for export has been inspected by the competent authority of a Member State and was found to comply with the principles of good manufacturing practice laid down pursuant to Article160.

AddedArticle 159 Active substances imported from third countries

Added1. At the request of a third country, the Commission shall assess whether that country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union.

AddedThe assessment shall take the form of a review of relevant documentation submitted by electronic means and, unless arrangements as referred to in Article 153(2) are in place that cover this area of activity, that assessment shall include an on-site review of the third country’s regulatory system and, if necessary, an observed inspection of one or more of the third country’s manufacturing sites for active substances.

Added2. Based on the assessment referred to in paragraph 1, the Commission may adopt implementing acts to include the third country in a list and to apply the requirements set out in the second subparagraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

AddedWhen assessing the third country pursuant to paragraph 1, the Commission shall take account of the following:

Added(a) the country’s rules for good manufacturing practice;

Added(b) the regularity of inspections to verify compliance with good manufacturing practice;

Added(c) the effectiveness of enforcement of good manufacturing practice;

Added(d) the regularity and rapidity of information provided by the third country relating to non-compliant manufacturers of active substances.

Added3. The Commission shall verify regularly whether the conditions laid down in paragraph 1 are fulfilled. The first verification shall take place no later than 3 years after the third country has been included in the list referred to in paragraph 2.

Added4. The Commission shall perform the assessment referred to in paragraph 1 and verification referred to in paragraph 3 in cooperation with the Agency and the competent authorities of the Member States.

AddedSection 3 Principles of good manufacturing and good distribution practices

AddedArticle 160 Rules applicable to medicinal products and active substances

AddedThe Commission mayis empowered to adopt implementingdelegated acts in accordance with Article 214(2)215 to supplement this Directive by specifying: [Am. 279]

Added(a) the principles of good manufacturing and good distribution practices for medicinal products complemented, where relevant, by specific measures applicable notably to pharmaceutical forms, medicinal products or manufacturing activities in line with good manufacturing principles;

Added(b) the principles of good manufacturing and good distribution practices for active substances.

Added(ba) measures to reduce the negative impact on the environment posed by the manufacturing of medicinal products. [Am. 280]

AddedWhere relevant, these principles shall be specified in coherence with any principles of good practices established under any other Union legal framework.

AddedArticle 161 Rules applicable to excipients

AddedThe Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients referred to in Article 147(2). Such risk assessment shall take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects.