Joanna Krakowiak

Permit from the president of URPL, not the Minister of Health

A change in the body responsible for issuing marketing authorisation for drugs should cut the time required to obtain approval in Poland.

From 1 May 2011, the authority issuing decisions permitting medicinal and biocidal products to be marketed in Poland, as well as permits to conduct clinical trials, is now the president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). Previously this official issued only decisions concerning medicinal devices. In other matters he served an advisory function, but the decisions were issued by the Minister of Health.

Under the URPL Act, which came into force at the beginning of May, the president of URPL obtained the status of a central administrative authority. Among the effects the new act will have on businesses, applications for decisions will be filed directly with URPL, rather than the Minister of Health, as before. If the decision by the president of URPL is unfavourable, the applicant will be able to seek reconsideration by the same official. His decisions will also be subject to review by the administrative court.

It is expected that vesting new authority in the president of URPL should reduce the waiting time for issuance of marketing authorisation for medicines under the national procedure. Under the earlier procedure, URPL prepared a draft of the proposed decision, which was forwarded to the Ministry of Health together with the files in the case. The minister then needed time to review the case and issue a decision.

Another new feature of the URPL Act is a conflict of interest provision under which the president, vice presidents and staff of URPL may not serve as a member of the authorities of a company that has been issued or is seeking a permit by the president of URPL, or serve as a representative, attorney, employee or service provider or hold shares in such company. URPL officials will also be required to file declarations that they do not have any conflict of interest.

Joanna Krakowiak, Life Science & Regulatory Law practice, Wardyński & Partners

This text was published on 13 May 2011 in Dziennik Gazeta Prawna daily, in the “Commercial Law Academy” series