This section is about Pharmaceutical Regulatory Affairs.
Contributions from members are very welcome. Every article is published with full credentials about Author. Register as the member and publish your professional article.
Czech Republic
Written by Rita Krezo
Monday, 06 October 2008
Update on e-CTD submission in Czech Republic
„Special cases“ according to updated guideline REG-84- submission in eCTD format,
To the attention of Marketing Authorisation Holders In view of updating the National Medicines Agency’s (NMA) data base concerning representatives appointed by marketing authorisation holders (MAH) for relationships with the Agency, the NMA requires submission within 30 days as of posting of the present notification in the NMA website of the original official appointment letter, signed by the MAH.
The appointment letter shall specify the following identification data of the MAH representative:
- name and surname
- address
- telephone number (mobile telephone number included)
- fax number
- e-mail address
Appointment letters are to be delivered by mail or submitted at the Documents, Samples Admissions Bureau within the timetable for work with the general public.
To the attention of Holders of Marketing Authorisations granted through centralised procedure
Even though notification of the National Medicines Agency (NMA) on placement of the market of medicinal products authorised through centralised procedure is not mandatory (notification being made to the EMEA), the NMA is however interested in ensuring Romanian patients’ access to this category of medicinal products as well. Therefore, we think it to the benefit of all parties involved that Marketing Authorisation Holders also notify the NMA on placement, discontinuation or temporary cessation on the Romanian market of such medicinal products. Thank you for your collaboration.
the General Rules of Administrative Proceedings and Services
With a view to improving the public profile of the proceedings of administrative authorities where the majority of citizens and organization are concerned, such as:
- to place more emphasis on the service aspects of executive branches by way of substantially simplifying the procedures required from clients, and by opening new ways for faster and simpler handling of the majority of cases by putting to use modern means of electronics and information technology,
- to satisfy the requirement of harmony with other Member States of the European Union, to pave the way for expanding the possibilities of international cooperation in official proceedings, and for direct collaboration with foreign authorities,
- to provide a transparent legal background for the relationship between the clients and other parties to the proceeding with the authorities,
- to uphold the rights of clients in a manner and to the extent commonly acceptable in any democracy, whereas to leave the way open for the discharge of obligations on a voluntary basis,
- to afford priority to general provisions so as to provide a framework of guarantees for special rules of procedure, Parliament has adopted the following Act:
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 recognizing the importance of professional self-regulation, the Parliament hereby passes the following Act to regulate business advertising activity for the purposes of achieving fair communication with consumers, protecting the interests of enterprises, observing the requirements of fair business practices, and facilitating the sale of goods and services.
As one door closes, businesses must look for their next opening. Today, the traditional strongholds of the pharmaceutical industry, the US and Europe, are witnessing a downturn in growth to around 6% a year. This is the result not only of problems in the broader economy, but also the loss of marketing exclusivity by products in a number of major therapeutic categories; lower contributions from new products because of increased scrutiny of their value; and slower take-up by doctors and healthcare systems.
OTC Medicinal Products Subject to Sales Restriction - Implementation of a New Category
The State Institute for Drug Control (SÚKL) in Czech Republic has been preparing the implementation of a new category of supply of medicinal products, “OTC medicinal products subject to sales restriction” on the grounds of provisions of Section 39 (3) of the new Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, asamended (“Act on Pharmaceuticals”).
Whole 8 pages article is availabel for download at Repository of Faramavita.Net
Starting with May 19th 2008, the National Medicine Agency in Romania has increased the tariffs for evaluation of all types of applications (obtaining marketing authorizations via national procedure/ MRP and DCP, for variations, for renewals of MA, for clinical trials etc.).
Nanotechnology is the emerging scientific field which includes the study of small, thin, carbon-based materials known as nanotubes (also called CNTs), which are becoming widely used in a plethora of products ranging from technologically advanced items utilized by NASA to everyday items used in the home. These nanotubes are increasingly popular due to their light weight and supreme strength, which is said to be stronger than steel.
As the variety of uses for nanotubes increases, researchers continue to do studies and tests related to the consequences of nanotube use. Current research suggests that exposure to long multi-walled carbon-based nanotubes may lead to the development of mesothelioma, a deadly form of cancer that affects the lining of the lungs and has no known cure. Scientists claim that there is no cause for immediate concern, but that further testing related to nanotube exposure and the onset of mesothelioma is crucial.
FarmavitaR+ Journal 
Update on e-CTD submission in Czech Republic
Business Advertising Activity
OTC Medicinal Products Subject to Sales Restriction - Implementation of a New Category 
