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URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning content of Supplement 8.3 of eighth edition of European Pharmacopoeia (Ph. Eur.).

08.01.2015
This document is an announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning content of Supplement 8.3 of eighth edition of ...

EMA: Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS)/limited market - draft

08.01.2015
This guidance document relates to requests from applicants seeking to access incentives for MUMS/limited market products where a request for classification is made to the Committee for Medicinal ...

Polish Parliament: The act of December 19, 2014 concerning amendment of act - Pharmaceutical Law and other acts.

08.01.2015
This document is a final version of the act of December 19, 2014 concerning amendment of act - Pharmaceutical Law and other acts. ...

EMA: Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products

08.01.2015
This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor IX products, which are ...

EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

08.01.2015
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on ...

EMA: Draft guideline on the use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies

18.12.2014
The scope of this document is to describe the basis and regulatory requirements for the use of minimal residue disease (MRD) as an intermediate endpoint to predict clinical benefit in trials in ...

Polish Parliament: The act of December 5, 2014 concerning amendment of act - Pharmaceutical Law and other acts.

18.12.2014
This document is The act of December 5, 2014 concerning amendment of act - Pharmaceutical Law and other acts. ...

FDA: Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration

18.12.2014
This guidance specifies the unique facility identifier (UFI) system for registration of domestic and foreign drug establishments. This guidance is intended to address provisions set forth in ...

EMA: Procedure for reporting of pharmacovigilance inspections requested by the CVMP

18.12.2014
In this procedure a pharmacovigilance (PhV) inspection reports related to inspections requested by the Committee for Medicinal Products for Veterinary Use (CVMP) are detailed. The definitions, ...

EMA: Recommendations for the implementation of the exemptions to the labelling and package-leaflet obligations in the centralised procedure

11.12.2014
Companies developing human medicines that are not delivered directly to patients or where there are availability issues may be exempt from some of the obligations for labelling or package ...

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