Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
Registration is now open for RAPS Euro Convergence 2021! Attend to join peers from EU and around the world to gain insights and exchange ideas on the regions most pressing issues.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
Posted 16 July 2015 | By Michael Mezher
To boost transparency for re-exported drugs, the European Medicines Agency (EMA) has created a new publicly available online register for parallel distribution notices.
Parallel distribution, often referred to as re-exportation, allows companies in the EU to distribute centrally authorized medicines between member states, independent of their marketing authorization holder. This practice makes it possible for cheap drugs in one Member State to be distributed to another where they can be sold for a profit.
Parallel distribution is allowed under European free-trade laws, and specifically for medicinal products under Regulation (EC) No 726/2004, which tasks EMA with:
"Checking that the conditions laid down in Community legislation on medicinal products and in the marketing authorisations are observed in the case of parallel distribution of medicinal products authorised in accordance with this Regulation."
And in Article 76(3) and (4) of Directive 2001/83/EC, which states:
"(3) Any distributor, not being the marketing authorisation holder, who imports a medicinal product from another Member State shall notify the marketing authorisation holder and the competent authority in the Member State to which the medicinal product will be imported of his intention to import that product.""(4) In the case of medicinal products which have been granted an authorisation pursuant to Regulation (EC) No 726/2004, the distributor shall submit the notification in accordance with paragraph 3 of this Article to the marketing authorisation holder and the Agency. A fee shall be payable to the Agency for checking that the conditions laid down in Union legislation on medicinal products and in the marketing authorisations are observed."
"(3) Any distributor, not being the marketing authorisation holder, who imports a medicinal product from another Member State shall notify the marketing authorisation holder and the competent authority in the Member State to which the medicinal product will be imported of his intention to import that product."
"(4) In the case of medicinal products which have been granted an authorisation pursuant to Regulation (EC) No 726/2004, the distributor shall submit the notification in accordance with paragraph 3 of this Article to the marketing authorisation holder and the Agency. A fee shall be payable to the Agency for checking that the conditions laid down in Union legislation on medicinal products and in the marketing authorisations are observed."
To distribute centrally authorized medicines in this manner, distributors must notify a product's marketing authorization holder and EMA, which will then review the request and verify that the distributed product, as well as its label and packaging, meet the requirements of the destination Member State.
Previously, EMA would publish the notifications it received for parallel distribution requests on a monthly basis. However, with the number of notices in the thousands each year, this method of publishing was difficult to keep track of for both regulators and companies involved in the process.
By moving parallel distribution notices to a new publicly available online register, EMA says it will be easier for national regulators, distributors, pharmaceuticals manufacturers, patients and healthcare professionals to keep tabs on what products are being distributed in this manner.
EMA says the register currently holds more than 15,000 notices and will continue to be updated monthly. Anyone interested in searching for a parallel distribution notice can do so by searching the register by product name, strength, packaging size, pharmaceutical form, EU number, marketing authorization holder and/or parallel distributor.
Once a notice has been selected, the register will display the product's information, the date of the notice and the member state(s) of origin and destination.
EMA Press Release
Tags: Distribution, Parallel distribution, re-export
Regulatory Focus newsletters
All the biggest regulatory news and happenings.