What changed between the plenary report and the adopted text

Added:Chapter XII Wholesale distribution and sale at a distance

Added:Section 1 Wholesale distribution and brokering of medicinal products

Added:Article 162 Wholesale distribution of medicinal products

Added:1. Without prejudice to Article 5, Member States shall take all appropriate action to ensure that only medicinal products in respect of which a marketing authorisation has been granted in accordance with Union law are distributed on their territory.

Added:2. In the case of wholesale distribution including storage, medicinal products shall be covered by either a centralised marketing authorisation or by a national marketing authorisation.

Added:3. Distributors who intend to import a medicinal product from another Member State shall notify the marketing authorisation holder and the competent authority of the Member State to which the medicinal product is to be imported of their intention to import that medicinal product.

Added:4. In the case of medicinal products covered by a national marketing authorisation, the notification referred to in paragraph 3 to the competent authority of the Member State shall be without prejudice to additional procedures provided for in the legislation of that Member State and to fees payable to the competent authority of the Member State for examining the notification.

Added:5. In the case of medicinal products covered by a centralised marketing authorisation, the distributor shall submit the same notification referred to in paragraph 3 to the Agency which will be in charge of checking that the conditions laid down in Union law on medicinal products and in the marketing authorisations are observed. For this check, a fee shall be payable to the Agency.

Added:Article 163 Authorisation for wholesale distribution of medicinal products

Added:1. The competent authority of the Member State concerned shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to an authorisation to engage in activity as a wholesaler in medicinal products (“wholesale distribution authorisation”). The wholesale distribution authorisation shall indicate the premises, the categories of medicinal products and the wholesale distribution operations for which it is valid. [Am. 281]

Added:2. Where persons authorised or entitled to supply medicinal products to the public may also, under national law, engage in wholesale business, such persons shall be subject to the authorisation provided for in paragraph 1.

Added:3. A manufacturing authorisation required under Article 142 shall include an authorisation to distribute by wholesale the medicinal products that it covers. A wholesale distribution authorisation shall not give dispensation from the obligation set out in Article 142 to hold a manufacturing authorisation and to comply with the conditions set out in that respect, even where the manufacturing or import business is secondary.

Added:4. The competent authority of the Member State concerned shall enter the information relating to the wholesale distribution authorisations in the Union database referred to in Article 188(15).

Added:5. The competent authority of the Member State that granted the wholesale distribution authorisation for premises located in its territory shall ensure that controls of the persons authorised to engage in activity as a wholesaler in medicinal products, and inspections of their premises, are carried out at an appropriate frequency.

Added:The competent authority of the Member State that granted the wholesale distribution authorisation shall suspend or revoke it if the conditions for granting it set out in Article 162 cease to be met. In such event the Member State shall without undue delay inform the other Member States and the Commission thereof.

Added:6. Where a competent authority of a Member State considers that the conditions for granting a wholesale distribution authorisation set out in Article 162 are not met with respect to a wholesale distribution authorisation granted by the competent authority of another Member State, it shall without undue delay inform the Commission and the competent authority of the other Member State thereof. The competent authority of the other Member State shall take the measures it considers necessary and shall inform the Commission and the competent authority of the first Member State of those measures and the reasons for them.

Added:Article 164 Requirements for a wholesale distribution authorisation

Added:1. In order to obtain a wholesale distribution authorisation, applicants shall submit an application by electronic means to the competent authority of the Member State concerned.

Added:2. The application referred to in paragraph 1 shall include the following particulars:

Added:(a) a confirmation and proof that the applicants have at their disposal suitable and adequate premises, installations and equipment, to ensure proper conservation and distribution of the medicinal products;

Added:(b) a confirmation and proof that the applicants have at their disposal appropriately trained staff, and in particular, a qualified person designated as responsible, meeting the conditions provided for by the legislation of the Member State concerned;

Added:(c) an undertaking to fulfil the obligations incumbent on them under the terms of Article 166.

Added:Article 165 Granting of a wholesale distribution authorisation

Added:1. The official representatives of the competent authority of the Member State concerned shall carry out an inspection to confirm the accuracy of the particulars provided in accordance with Article 164.

Added:Where the accuracy of the particulars is confirmed in accordance with the first subparagraph and no later than 90 days after the receipt of the application submitted in accordance with Article164, the competent authority of the Member State shall grant or refuse a wholesale distribution authorisation.

Added:2. The competent authority of the Member State concerned may require the applicant to supply, by electronic means, all necessary information concerning the particulars for granting the wholesale distribution authorisation. In such case, the period laid down in paragraph 1 shall be suspended until the requisite additional information is supplied.

Added:3. The competent authority of the Member State may grant a wholesale distribution authorisation subject to conditions.

Added:4. The wholesale distribution authorisation shall apply only to the premises specified in the authorisation.

Added:Article 166 Obligations of the wholesale distribution authorisation holder

Added:1. Member States shall ensure that wholesale distribution authorisation holders shall:

Added:(a) have at their disposal the services of staff who comply with the legal requirements existing in the Member State as regards wholesale distribution;

Added:(b) allow the official representatives of the competent authority of the Member State access to their premises, installations and equipment referred to in Article 164(2), point (a), at all times;

Added:(c) obtain, including by financial transactions, their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation in the Union or a manufacturing authorisation referred to in Article 163(3);

Added:(d) supply, including by financial transaction, medicinal products only to persons who are themselves wholesale distribution authorisation holders or who are authorised or entitled to supply medicinal products to the public;

Added:(e) verify that the medicinal products received are not falsified by checking the safety features on the outer packaging, in accordance with the requirements laid down in the delegated acts adopted pursuant to Article 67(2), second subparagraph;

Added:(f) have an emergency plan that ensures effective implementation of any recall from the market ordered by the competent authorities or carried out in cooperation with the manufacturer or marketing authorisation holder for the medicinal product concerned;

Added:(g) keep records giving, for any medicinal products received, dispatched or brokered, at least the following information:

Added:(i) the date of receipt, dispatch or brokering of the medicinal product,

Added:(ii) the name of the medicinal product,

Added:(iii) the quantity of the medicinal product received, supplied or brokered,

Added:(iv) the name and address of the supplier of the medicinal product or the consignee, as appropriate,

Added:(v) the batch number of the medicinal products, at least for medicinal products bearing the safety features referred to in Article 67;

Added:(h) keep the records referred to in point (g) available to the competent authorities of the Member States, for inspection purposes, for a period of five years;

Added:(i) comply with the principles of good distribution practices for medicinal products laid down in Article 160;

Added:(j) maintain a quality system setting out responsibilities, processes and risk management measures in relation to their activities;

Added:(k) immediately inform the competent authority of the Member State and, where applicable, the marketing authorisation holder, of medicinal products they receive or are offered that they identify as falsified or suspect to be falsified;

Added:(l) continuously guarantee the appropriate and continued supply of an adequate range of medicinal products to meet the requirements of a specific geographical area, and deliver the supplies requested over the whole of the area in question, within a reasonable timeframe, which shall be defined in the national legislation;

Added:(m) cooperate with all relevant stakeholders, including marketing authorisation holders and competent authorities of the Member States on the security of supply. [Am. 282]

Added:2. Where the medicinal product is obtained from another wholesale distributor, the wholesale distribution authorisation holders obtaining the product shall verify compliance with the principles of good distribution practices by the supplying wholesale distributor. This includes verifying whether the supplying wholesale distributor holds a wholesale distribution authorisation, or a manufacturing authorisation referred to in Article 163(3).

Added:3. Where the medicinal product is obtained from a manufacturer or importer, wholesale distribution authorisation holders shall verify that the manufacturer or importer holds a manufacturing authorisation.

Added:4. Where the medicinal product is obtained through brokering of medicinal products, wholesale distribution authorisation holders shall verify that the person brokering the medicinal product fulfils the requirements set out in Article 171.

Added:Article 167 Obligation of supply of medicinal products

Added:1. With regard to the supply of medicinal products to pharmacists and persons authorised or entitled to supply medicinal products to the public, Member States shall not impose upon the wholesale distribution authorisation holder that has been granted by another Member State any obligation, in particular public service obligations, more stringent than those they impose on persons whom they have themselves authorised to engage in equivalent activities.

Added:2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Added:3. The arrangements for implementing this Article should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.

Added:Article 168 Documentation accompanying supplied medicinal products

Added:1. For all supplies of medicinal products to a person authorised or entitled to supply medicinal products to the public in the Member State concerned, the authorised wholesaler must encloseshall provide a document, which may be submitted in electronic format, that makes it possible to ascertain the following: [Am. 283]

Added:(a) the date of the supply;

Added:(b) the name and pharmaceutical form of the medicinal product;

Added:(c) the quantity of the medicinal product supplied;