nCADREAC Agreement

  nCADREAC Members

  Contact points

  Simplified procedures

  Products authorized following the simplified procedure for MRP
              Bulgaria
              Croatia
              Romania

   Having our common goal in mind, to protect public health in our countries by ensuring the use of medicinal products meeting international standards of quality, efficacy and safety as well as ensuring that relevant information is provided on such products,
   Taking into account, our similar past and present issues, on one hand as well as our previous collaborations, on the other hand,
   Considering the unambiguous success of the Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries (CADREAC),
   Considering our informal contacts already established,
   Considering that intensification of our collaboration could be beneficial on both conceptual and technical levels,
   Supported also by European Union (EU) officials and encouraged by the WHO Regional Office for Europe,
   We, the Heads of Drug Regulatory Authorities in Central and Eastern European Countries (further on: Signatories)
   During the CADREAC Annual Assembly, March 2004 in Bucharest, followed by many discussions
   Have agreed to sign the present Agreement in order to start a new informal collaboration.

   (1) To facilitate implementation of EU standards and professional obligations to drug regulations into practice.
   (2) To create a better environment and broader possibilities for Signatories outside the EU to be involved in professional activities organised by the EU.
   (3) To facilitate introduction of mutually recognisable procedures and activities relating to „Good Practices" in accordance with EU regulatory principles for the assessment and marketing authorisation of medicinal products.
   (4) To establish a forum in which joint strategies concerning either approaching or later EU accession or working together with the EU are developed and particularities referring to the group as a whole are elaborated among Signatories and/or together with EU structures to avoid unnecessary duplication of work and save resources.
   (5) To facilitate the preparation of future drug regulatory meetings of Central and Eastern European countries and EU member states.
   (6) To co-ordinate the participation of Signatories in the European network of regulatory information on medicinal products.

   (1) This Agreement is concluded between Drug Regulatory Authorities (Participating DRAs), and not between States. If one State/Country has more than one drug regulatory authority, all the latter have the possibility to participate in this Agreement.
   (2) There are different kinds of Signatory regulatory authorities :
     a) regulatory authorities in EU member states
     b) regulatory authorities in EU candidate countries (that have a signed association agreement with the EU)
     c) regulatory authorities in non-EU-candidate countries that have valid mutual recognition agreement(s) with EU covering certain fields of drug regulations
     d) regulatory authorities in other interested Central and Eastern European countries.
   Regulatory authorities of a) and b) type are called active members of this Agreement.
   Regulatory authorities of c) type are also active members in field(s) in which the mutual recognition agreement(s) have been signed with the EU.
   Regulatory authorities of d) type are called collaborative members of this Agreement.
   (3) Participation in any activity of this Agreement or implementation of any of its recommendations is voluntary for all Participating DRAs.
   (4) Without   prejudice   to   the   EU   internal   confidentiality   rules,   all   Participating DRAs may have access to all the information generated within the framework of the Collaboration.
   (5) The present Collaboration exclusively involves DRAs, with no legal obligation. Thus, every Signatory should decide and take adequate steps, relevant to their country (e.g. inform or receive consent from their Government) in order to be able to participate in the Agreement.
   (6) Whenever an active member candidate country is entrusted by the others to represent the Collaboration in a EU body (see Article 5), it (the delegated person) represents the Collaboration, not their DRA or country.

   (1) This Collaboration has no formal Chair. The DRA that hosts the CADREAC Annual Meeting serves the collaboration as Administrative Secretariat until the next Annual Meeting. Thus, outside the scope of its mentioned representations, the Collaboration may be approached (e.g., by the EU, non-participating DRAs, governmental, non-governmental and private organisations, etc.) by contacting any of the Participating DRAs, although approaching the Administrative Secretariat is encouraged.
   (2) The DRA (its actual Head, who has the right of a Signatory, etc.) approached from outside the Collaboration according to (1) on issues of relevance for the Collaboration, considered as such by the DRA, shall consult the Participating DRAs accordingly in terms of the answer or any other activities connected with the approach.
  (3) The governing body of the Collaborations is the Assembly of the in office Heads of the Participating DRAs..

   (1) The Head of the Participating DRA, if temporarily unable to participate personally (in a meeting or answering urgent questions, etc.) may appoint a deputy or other person to act, for the given occasion, on his/her behalf.
   (2) The Assembly may be convened by any Signatory.
   (3) All   forms   of communication  (personal  meeting, telephone  conference, quick exchange of opinions by E-mail or telefax) may be considered as an Assembly, although organisation of a face to face meeting of nCADREAC DRAs (The CADREAC Annual Meeting) is required at least once a year.
   (4) The Annual Meeting is convened by the Participating DRA (Signatory) that will host it.
   (5) The Assembly is taken as convened when a quorum of Signatories (or, according to Article 4(1), deputies, etc.), is present.
   (6) Without prejudice to what is stated in Article 3(1), every Assembly shall elect a chairperson. As a rule, the chairperson is from the host DRA. Election is undertaken for the exclusive purpose of facilitating work of the Assembly and lasts until its end only.
   (7) The Assembly decides on the basis of consensus reached. It is the actual chairperson's task to lead the discussion until consensus is reached. Issues for which no consensus could be reached shall be dropped. This does not restrict freedom of any Participating DRA to apply measures, dropped by the Collaboration lacking the consensus, on an individual basis.
   (8) Participating DRAs unable to be represented in the Assembly are informed upon proposed decisions by appropriate means. Should no answer be received within 8 days, lack of reply is considered as agreement to the proposed decision.

   (1) Having the possibility for participation in an EU body (working group, etc.) for EU candidate countries (Article 2(2)b)), provided by the EU (Commission, EMEA, etc.), entitled Signatories, shall as soon as possible, identify candidate country DRAs in the position to provide a knowledgeable, skilled and competent person, with a good command of English, to meetings of agreed EU bodies, as a rule, for a one year period.
   (2) Having completed the lists under (1), entitled Signatories elect those who represent the Collaboration as observer.
   (3) When elected to represent the Collaboration for a given year, the entitled Signatory has the obligation to appoint one single person, either working at the DRA or elsewhere, who complies with the requirements under (1) and will presumably be accepted by the EU body. Only in well justified cases may this representative be substituted by another person. Substitution is co-ordinated by the entitled Signatory. Change of persons within the one year period is strongly discouraged. The name and data of the observer (short CV, address, phone and fax numbers, etc.) should be communicated to all Signatories in due time.
   (4) Within their period of representation, through the DRA which appointed them, nCADREAC observers are the contact and information dissemination points of the Collaboration for the respective EU body.   The responsibility of the observer is to inform in writing all Participating DRAs on the outcome of the representation accordingly. Similarly, it is the Signatories' task that the observer receives all relevant information from Participating DRAs.
   (5) Should the observer for any reason resign for a given year, a new observer should be appointed as specified under (2). All Signatories are to be informed on the resignation in due time.

   (1) Applying methodological principles of Article 5 but in respect of  EU rules concerned Signatories may establish any forms of „internal" co-operation (e.g., working groups, joint visits, etc.) aiming to accomplish  the objective specified under Article l (3).
   (2) Working groups, that may also involve invited experts, are established and their chairpersons elected according to principles under Articles 4 and 5.

   (1) As a rule, Participating DRAs are obliged to meet their expenses, as related to the Collaboration.
   (2) Financial support for the Collaboration may be sent to and received by any Participating DRA but shall be accounted to and used on consent of the Assembly.

   (1) The official working language of the Collaboration, both during Assemblies and working group meetings and in the written Communication is English. Other language (or mother tongue) may only be used if proper interpretation is provided by the DRA that is represented by the delegate using this language.
   (2) This Collaboration becomes effective 30 days after dating and signing by the sixth future active member.
   (3) This Collaboration is open for any DRA in Central and Eastern Europe (in its widest sense); joining is performed through signing the present agreement by the Head of respective DRA, with subsequent information of Signatories.   
   (4) Any Participating DRA is free to terminate its Collaboration by sending a letter to the Administrative Secretariat, 3 months before termination if possible with a clear indication to this effect; the Administrative Secretariat is obliged to disseminate this to the others. Should Participating DRA cease to exist, its (former) head must notify the Administrative Secretariat accordingly.
   (5) The Collaboration (at least, under the present name) ceases to exist should there remain less than six active participants as consequence of terminations according to (4)

   (1) Whenever an amendment is made to the hereby text of the collaboration, the amended highlighted version and the amended version must be archived. The amended version is taken as official.
   (2) The present agreement is archived in the National Institute of Pharmacy, H-1015 Budapest, Zrinyi Street 3, should an Assembly not decide otherwise.

Active members
Dated Signatories

Collaborative members
Dated Signatories

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