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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:

(a) the product name and active ingredient of the tiered-priced product and sufficient information to verify which disease it prevents, diagnoses or treats;

(b) the price offered in relation to either of the optional price calculations set out in Article 3 in sufficient detail to enable verification. Instead of submitting such detailed information, the applicant may submit a certificate, issued by an independent auditor, stating that the price has been verified and corresponds to one of the criteria set out in Annex III. The independent auditor shall be appointed in agreement between the manufacturer and the Commission. Any information submitted by the applicant to the auditor shall remain confidential;

(c) the country or countries of destination to which the applicant intends to sell the product concerned;

(d) the code number based on the Combined Nomenclature as set out in Annex I to Council Regulation (EEC) No 2658/87 and, where appropriate, supplemented by TARIC subdivisions, to identify unambiguously the goods concerned; and (e) any measures taken by the manufacturer or exporter to make the tiered-priced product easily distinguishable from identical products offered for sale within the Union.

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.