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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.