Poland Drug Product Registration

MOH

Ministry of Health 

MOH Website 

https://www.archiwum.mz.gov.pl/ 

Regulatory Authority 

Office for Registration of Medicinal Products, Medical Devices and Biocides

Regulatory Website 

https://www.urpl.gov.pl/

Local Authorized Representative Required

Yes

Drug Approval Process

Medicinal products may be placed on the market only if the competent authority issues an appropriate decision authorizing the marketing of the medicinal product.

Before issuing such a decision, the competent authority confirms whether a given medicinal product is of appropriate quality, whether it is safe and effective. The assessment is based on the application submitted by the responsible entity and the documentation attached to it.

The President of the Office issues a decision on the marketing authorization of medicinal products registered under the national, mutual recognition (MRP) and decentralized (DCP) procedures.

• Mutual Recognition Procedure

When a pharmaceutical product has already received marketing authorization in one EU member state (reference country: RMS) and the manufacturer wishes to register it in another EU nation (concerned country: CMS), the Mutual Recognition Procedure (MRP) is utilized. An evaluation report created by RMS serves as the foundation for CMS’s assessment of a particular medication product.

The 90-day MRP process is involved. CMS must verify the national versions of the information forms submitted to the MAH within 30 days of its completion to grant a national marketing authorization decision. Documents authorized during the MRP procedure serve as the basis for the preparation of national versions of information forms.

• Decentralized Procedure

When the pharmaceutical product sought has not yet received approval in any EU Member State, the Decentralized Procedure (DCP) is employed. The reference country, RMS, is identified as the responsible entity in this scenario, and it will be their responsibility to compile the assessment report. States concerned: CMS bases its decision on the evaluation report RMS has prepared.

210 days are needed for the DPC process. The participating nations (RMS and CMS) have 30 days from completion to confirm the national versions of the information forms sent to the MAH and to make a national marketing authorization decision. National information form versions are created using the accepted papers from the DCP process.

• Centralized Process

The Centralized Procedure (CP), which was established by Regulation (EC) No. 726/2004 of the European Parliament and of the Council on March 31, 2004, permits the marketing of pharmaceuticals in all EEA member countries—Iceland, Norway, and Liechtenstein—as well as in the European Union. 

The European Medicines Agency (EMA) reviews the marketing authorization application, and the European Commission renders a judgment based on the Committee for Medicinal Products for Human Use’s (CHMP) scientific opinion. 

Pharmaceuticals made using biotechnological processes, advanced therapy pharmaceuticals, pharmaceuticals with orphan drug status, and pharmaceuticals for human use with a novel active ingredient whose therapeutic indications include acquired immunodeficiency syndrome, cancer, neurodegenerative diseases, diabetes, autoimmune diseases, and other immune dysfunctions and viral diseases are all covered by registration under the centralized procedure.

Products that constitute a significant clinical, scientific, or technological innovation for which obtaining authorization at the community level is in the best interests of patients may also be registered through the centralized system. 

When a generic product’s attributes match those of a medication authorized using a centralized method and its name is the same throughout all EEA countries, the generic product may likewise be centrally registered.

• National Procedure

The Act of September 6, 2001, Pharmaceutical Law (Journal of Laws of 2008, No. 45, item 271, as modified) and its implementing rules, and the national procedure, govern the admission of medical items into circulation. A product must be registered by applying along with the relevant supporting materials and proof of its efficacy, safety, and quality. 

Following the submission of the registration dossier, an assessment is made to determine whether the application was accurately completed, whether the money needed was paid, and whether all necessary papers or portions of the documentation were attached.

The marketing authorization procedure takes two hundred and ninety-one days.