1.   This Regulation lays down:

2.   For the purposes of this Regulation:

1.   The importation into the Union of tiered-priced products for the purposes of release for free circulation, re-export, placing under suspensive procedures or placing in a free zone or free warehouse shall be prohibited.

2.   The following shall be exempted from the prohibition regarding tiered-priced products as set out in paragraph 1:

1.   In order for products to benefit from this Regulation, manufacturers or exporters of pharmaceutical products shall submit applications to the Commission.

2.   Any application addressed to the Commission shall contain the following information:

3.   Where the Commission determines that a product fulfils the requirements set out in this Regulation, the Commission shall be empowered to adopt delegated acts in accordance with Article 5 to add the product concerned to Annex I at the next update. The Commission shall inform the applicant of its decision within 15 days of its adoption thereof.

Where a delay in the addition of a product to Annex I would cause a delay in responding to an urgent need for access to affordable essential medicines in a developing country, and therefore imperative grounds of urgency so require, the procedure provided for in Article 6 shall apply to delegated acts adopted pursuant to the first subparagraph.

4.   If an application is not sufficiently detailed for a review as to substance, the Commission shall request the applicant in writing to submit such missing information. If the applicant does not complete the application within the time period set out in that written request, the application shall be null and void.

5.   If the Commission finds that the application does not fulfil the criteria set out in this Regulation, the application shall be rejected and the applicant shall be informed within 15 days of the date of the decision. Nothing shall prevent the applicant from submitting a modified application for the same product.

6.   Products destined to be donated to recipients in one of the countries listed in Annex II may be the subject of a notification to that effect for the purposes of approval and insertion in Annex I.

7.   Annex I shall be updated every second month by the Commission.

8.   The Commission shall be empowered to adopt delegated acts in accordance with Article 5 to amend Annexes II, III and IV where necessary in order to revise the list of diseases, the countries of destination covered by this Regulation, as well as the formulae used to identify tiered-priced products, in the light of the experience gained from its application or to respond to a health crisis.

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

2.   The power to adopt delegated acts referred to in Article 4(3) and (8) shall be conferred on the Commission for a period of 5 years from 20 February 2014. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the 5-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.

3.   The delegation of power referred to in Article 4(3) and (8) 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 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.

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

5.   A delegated act adopted pursuant to Article 4(3) shall enter into force only if no objection has been expressed either by the European Parliament or 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.

6.   A delegated act adopted pursuant to Article 4(8) shall enter into force only if no objection has been expressed either by the European Parliament or 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 four months at the initiative of the European Parliament or of the Council.

1.   Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure laid down in this Article.

2.   Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 5(5) and (6). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or by the Council.

1.   Where there is reason to suspect that, contrary to the prohibition provided for in Article 2, tiered-priced products will be imported into the Union, customs authorities shall suspend the release of, or detain, the products concerned for the time necessary to obtain a decision of the competent authorities on the character of the merchandise. The period of suspension or detention shall not exceed 10 working days unless special circumstances apply, in which case the period may be extended by a maximum of 10 working days. Upon expiry of that period, the products shall be released, provided that all customs formalities have been complied with.

2.   It shall be sufficient reason for the customs authorities to suspend the release of, or detain, products if there is sufficient information available to consider that the product in question is tiered priced.

3.   The competent authority in the Member State concerned and the manufacturer or exporter mentioned in Annex I shall be informed without delay of the suspended release or detention of the products and shall receive all information available with respect to the products concerned. Due account shall be taken of national provisions on the protection of personal data, commercial and industrial secrecy, and professional and administrative confidentiality. The importer and, where appropriate, the exporter, shall be given ample opportunity to supply the competent authority with the information which it deems appropriate regarding the products.

4.   The procedure of suspension or detention of the goods shall be carried out at the expense of the importer. If it is not possible to recover those expenses from the importer, they may, in accordance with national legislation, be recovered from any other person responsible for the attempted illicit importation.

1.   If products suspended for release or detained by customs authorities are recognised by the competent authority as tiered-priced products under this Regulation, the competent authority shall ensure that those products are seized and disposed of in accordance with national legislation. Those procedures shall be carried out at the expense of the importer. If it is not possible to recover those expenses from the importer, they may, in accordance with national legislation, be recovered from any other person responsible for the attempted illicit importation.

2.   Where products suspended for release or detained by customs authorities subsequent to further control by the competent authority are found not to qualify as tiered-priced products under this Regulation, the customs authority shall release the products to the consignee, provided that all customs formalities have been complied with.

3.   The competent authority shall inform the Commission of all decisions adopted pursuant to this Regulation.

1.   The Commission shall monitor on an annual basis the volumes of exports of tiered-priced products listed in Annex I and exported to the countries of destination on the basis of information provided to it by pharmaceutical manufacturers and exporters. For this purpose a standard form shall be issued by the Commission. Manufacturers and exporters shall submit such sales reports annually for each tiered-priced product to the Commission on a confidential basis.

2.   The Commission shall report biennially to the European Parliament and to the Council on the volumes exported under tiered prices, including on the volumes exported within the framework of a partnership agreement agreed between the manufacturer and the government of a country of destination. The report shall examine the scope of countries and diseases and general criteria for the implementation of Article 3.

3.   The European Parliament may, within one month of submission of the Commission's report, invite the Commission to an ad hoc meeting of its responsible committee to present and explain any issues related to the application of this Regulation.

4.   No later than six months from the date of submission of the report to the European Parliament and to the Council, the Commission shall make the report public.

1.   The application of this Regulation shall in no circumstances interfere with procedures laid down in Directive 2001/83/EC of the European Parliament and of the Council (6) and Regulation (EC) No 726/2004 of the European Parliament and of the Council (7).

2.   This Regulation shall not interfere with intellectual property rights or rights of intellectual property owners.