All readers who are going to apply for trade mark registration for medicines in the Republic of Poland should consider not only the Act on Industrial Property Law and its related Regulations but also the procedure and requirements set by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

OFROMPMDABP is a government agency competent for matters related to evaluation of quality, efficacy and safety of medicinal products, medical devices and biocidal products. Trade mark owners should be aware of the existence of the announcement (this is a PDF file in Polish language) issued by the President of the Office on 12 March 2008. This document applies to the process of medicinal product naming and the substitution of names that were already issued.

• New name of a medicine product should differ from earlier registered product’s name in at least 3 letters and the new name can not include the sequence of more then two of the same letters. The applicant is required to issue a justified written statement in case of seeking a waiver from the above mentioned rules.
• New name can not lead to likelihood on confusion (in print, spelling and pronunciation) with regard to earlier registered name.
• New name can not give any promotion or advertising information related to application process.
• Signs such as ® and “TM” can not be a part of a new name.
• The name of a medicinal product shall not incorporate names or family names, this including family names of drug inventors, fictional characters assigned academic degrees or pseudonyms, as well as it shall not incorporate designations bringing religious connotations, geographical, historical or environmental names, or words considered as the offensive ones or which suggest such words.
• Where the name given to a pharmaceutical product is not accepted by the Office five days before the international stage (MRP, DCP) for the reason of its non-compliance with the above guidelines, the medicinal product will be registered under the common name provided with the name of the marketing authorization holder.

Categories: medicinal product | Polish law | trademark law.