9.

Article 4 of the Medicinal Products Law states in the relevant parts: ‘1. Subject to the reservation in paragraphs 3 and 4, medicinal products imported from outside Poland may be placed on the market without the need to obtain authorisation for them if their use is necessary for the purpose of saving the life or safeguarding the health of a patient, on condition that the medicinal product in question is allowed to be marketed in the country from which it was imported and holds an up-to-date marketing authorisation. 2. The basis for the importation of a medicinal product, as referred to in paragraph 1, is the requirement of the hospital or external doctor treating the patient, as confirmed by a consultant in the medical sector concerned. 3. The following medicinal products may not be placed on the market within the terms of paragraph 1: (1) those in respect of which the minister with responsibility for health-related matters has issued a decision refusing to grant authorisation, refusing to extend the duration of validity of an authorisation, or revoking authorisation; and (2) those containing the same active substance or substances, the same dosage and having the same form as medicinal products which have obtained authorisation, subject to the reservation in paragraph 3a. 3a. The rule in paragraph 3(2) shall not apply to medicinal products, as referred to in paragraph 1, the price of which is competitive in relation to the price of the medicinal product which has obtained authorisation within the terms of Article 3(1) or (2), on condition that the requirement has been expressed by a health insurance doctor and has been confirmed by a consultant in the medical sector concerned, and that the minister with responsibility for health-related matters has expressed, by way of a decision, his agreement to the importation of those products. 4. Medicinal products, as referred to in paragraph 1, which, having regard to the safety of their application or the scale of importation, must be granted marketing authorisation pursuant to Article 3(1), may also not be placed on the market. 5. Pharmacies, wholesalers and hospitals engaging in the commercial sale of medicinal products, as referred to in paragraph 1, shall maintain a register of those products. 6. On the basis of that register, a pharmaceutical wholesaler shall forward to the minister with responsibility for health-related matters, no later than 10 days after the end of each quarter, a summary list of imported medicinal products. 7. The minister with responsibility for health-related matters shall define, by way of regulation: (1) (repealed); (2) details relating to the method and form of importation from outside Poland of medicinal products as referred to in paragraph 1, with particular regard to: (a) the nature of the requirement; (b) the manner in which that minister confirms the circumstances referred to in paragraph 3; (c) the manner in which the President of the National Health Fund confirms the circumstances referred to in Article 36(4) of the Law of 27 August 2004 on health-care benefits financed out of public funds (Dziennik Ustaw No 210, section 2135, as subsequently amended); (d) the manner in which the register of imported medicinal products is maintained by wholesalers, pharmacists and hospitals; and (e) the scope of the information provided by a pharmaceutical wholesaler to the minister with responsibility for health-related matters.’