Categoria: Italian Regulatory Affairs News
Time extension – Adaptation of the patient leaflet of medicines authorized by national procedure to the format drafted by the Working Group on Quality Review of Documents
Time extension – Adaptation of the patient leaflet of medicines authorized by national procedure to the format drafted by the Working Group on Quality Review…
New guideline on Saudi Arabia medical devices
The Saudi Arabian competent authority has published a new guideline on the requirements for the labelling of medical devices.
Brazil, the new rule to facilitate cosmetics
Updates to the existing rules concerning cosmetics in Brazil. The national regulatory agency ANVISA has adopted new legislation according to which cosmetics will be exempt…
Expectorants, updates to information
The CMDh of the EMA has approved new recommendations for updating the product information for medicinal expectorants based on ambroxol and bromhexine to include safety…
Plant protection products, news regarding the stock disposal
News for the disposal methods of inventory stocks of phytosanitary products laid down by the ministerial decree contained in the note of 7th September, 2010,…
Hepatitis C, new updates
Further updates have been made to the list of regional centers authorized to prescribe medicinal products for the treatment of hepatitis C.
Statins, modifications to product information
Following the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA, the Pharmacovigilance Office of the Italian Medicines Agency has requested amendments to the printed…
Non-essential modifications
A new resolution has set out the methods of communication of non-essential modifications to manufacturing sites and/or the importation of non-sterile active substances and those of a…
Demand for cosmetics is growing worldwide
The demand of cosmetic products keep growing, especially in developing countries. A recent survey detected the world areas where importation of cosmetics will exceed the world mean rate in 2015 and…
FDA approves new stent
The US FDA has approved a new drug-releasing stent for percutaneous transluminal coronary angioplasty in the treatment of femoropopliteal occlusive disease.