ELECTRONIC PRODUCT INFORMATION (ePI)

The European Medicines Agency (EMA) and its European medicines regulatory network partners are working to enable the use of electronic…

READ

BILINGUALISM REQUIREMENT FOR MEDICINES IN THE PROVINCE OF BOLZANO AND POSSIBLE EXEMPTIONS

The Italian Decree n. 219/2006 (implementing 2001/83/EC Directive and following amendments) establishes that at least the information reported in the…

READ

CRITERIA FOR MARKETING AUTHORIZATION (MA) NUMBER(S) ASSIGNMENT BY AIFA IN THE CONTEXT OF NEW MA/EXTENSION OR VARIATION APPLICATIONS

The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) has provided Marketing Authorization Holders (MAH) with the criteria used to…

READ

AIFA REPORT ON TIMELINES FOR PRICING AND REIMBURSEMENT PROCEDURES IN THE PERIOD 2018-2022

On 27 April 2023, the Italian Medicines Agency (AIFA) published a report on the timelines of “Pricing and Reimbursement” procedures…

READ

SWITZERLAND AND THE US SIGNED AN MRA RELATING TO PHARMACEUTICAL GOOD MANUFACTURING PRACTICE

Mutual Recognition Agreements (MRAs) are internationally binding agreements between countries that aim to facilitate market access and optimize the use…

READ

SCIENTIFIC ADVICE TO MANUFACTURERS OF HIGH-RISK MEDICAL DEVICES

EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for all…

READ

PHARMACOECONOMIC AND BUDGET IMPACT ANALYSES SUBMITTED TO AIFA IN PRICE & REIMBURSEMENT DOSSIERS – REPORT 2022

In accordance with the AIFA Guidelines on the preparation of the Price and Reimbursement (P&R) dossiers, in force since 30…

READ

ASMF: NEWS ON ASMF SUBMISSION REQUIREMENTS IN ITALY

AIFA has recently published the updated procedures to be followed for the initial submission of an Active Substance Master File…

READ

SALES REPRESENTATIVES: REGIONAL REQUIREMENTS FOR PROMOTION TO HCPS

In accordance with Legislative Decree 219/2006, medical sales representatives are the only professional profiles that are allowed to promote medicinal…

READ

STEPWISE PIP: EMA SUPPORT FOR THE AUTHORISATION OF INNOVATIVE MEDICINES

The Paediatric Investigation Plan (PIP), introduced by Regulation (EC) No 1901/2006, is a research and development programme aimed at ensuring…

READ