The Difficulty in Readability Testing
Since readability testing became a necessity for better patient understanding of leaflets, there has been a plethora of ways to test a leaflet. To the outsider, presenting a leaflet to
Romania – Notice on Change of Access to Information on Centrally Authorised Medicinal Products
The NMA hereby informs you on replacement of PDF files in the “Useful Information” section of the main menu, containing the Romanian version of the Summary of Product Characteristics (SPC)
Business Advertising Activity
Hungarian National Institute of Pharmacy has published new guidelines in order to ensure the protection of consumer interests and sustain market competition which serves economic efficiency and social welfare, while
Marketing Authorisation for Medicines via Centralised Procedure in Turkey
Marketing authorisation could be laso granted for Turkey to comapnies on-going cantalised procedure by EMEA, according to investigation of FarmavitaR+ consultant from Istanbul, Turkey. An application sould be filed in
Healthcare Brands International Announces the Acquisition of Antula Holdings AB
Healthcare Brands International (HBI) announces the completion of a major step towards its goal of building a new international Over-the-Counter (OTC) healthcare business with the acquisition of Antula Holdings AB,
Regulatory About Cosmetic Ingredients
Many of the ingredients used in the cosmetic products are actually industrial strength chemicals, solvents and petroleum by-products. This is even true for many of the most expensive products available
Regulatory Affairs: The Hub of the Wheel
Pharmaceutical companies' regulatory affairs units are more vital than ever, but, traditionally, they have not been known for their flexibility. Peter Lassoff explains why this image is outdated, and how
Readability (QRD) Testing of Patinet Information Leaflet (PIL)
Since 2005, marketing authorization holders of medicines are required to have the patient information leafets for their products readability tested. The European Directive 2004/27/EC (a revision of Directive 2001/83/EC) defines
Hospital in the Home: Concept and Clinical Guidelines
Hospital in the Home (HITH) is the provision of hospital care in the comfort of the persons own home. In this patients are regarded as hospital inpatients and remain under
New Legal Framework for Harmonisation of the Data Exclusivity
The new periods of data exclusivity will only take effect for reference products applying for marketing authorisation after the new law is fully in effect (around November 2005). Therefore, the