CELEX: 51976PC0683
Language: en
Date: 1976-12-22
Title: COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS Draft Rules of Procédure

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (76) 683
Vol. 1976/0205
 ---pagebreak--- Disclaimer
Conformément au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983
concernant l'ouverture au public des archives historiques de la Communauté économique
européenne et de la Communauté européenne de l'énergie atomique (JO L 43 du 15.2.1983,
p. 1), tel que modifié par le règlement (CE, Euratom) n° 1700/2003 du 22 septembre 2003
(JO L 243 du 27.9.2003, p. 1), ce dossier est ouvert au public. Le cas échéant, les documents
classifiés présents dans ce dossier ont été déclassifiés conformément à l'article 5 dudit
règlement.
In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983
concerning the opening to the public of the historical archives of the European Economic
Community and the European Atomic Energy Community (OJ L 43, 15.2.1983, p. 1), as
amended by Regulation (EC, Euratom) No 1700/2003 of 22 September 2003 (OJ L 243,
27.9.2003, p. 1), this file is open to the public. Where necessary, classified documents in this
file have been declassified in conformity with Article 5 of the aforementioned regulation.
In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1.
Februar 1983 über die Freigabe der historischen Archive der Europäischen
Wirtschaftsgemeinschaft und der Europäischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983,
S. 1), geändert durch die Verordnung (EG, Euratom) Nr. 1700/2003 vom 22. September 2003
(ABI. L 243 vom 27.9.2003, S. 1), ist diese Datei der Öffentlichkeit zugänglich. Soweit
erforderlich, wurden die Verschlusssachen in dieser Datei in Übereinstimmung mit Artikel 5
der genannten Verordnung freigegeben.
 ---pagebreak---   COMMISSION OF THE EUROPEAN COMMUNITIES
                                                   COM(76)683 final
                                                   Brussels . 22 December 1976
                 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS
                          Draft Rules of Procédure
C0M(76 ) 683 final
 ---pagebreak---                          Fxplanatory mémorandum
By Council Directive 75 / 319/ TEC of 20 Fay 1975 a Committee on Proprietary
f.edicinal Products was set up with the main task to discuss concrete cases
regarding authorization of proprietary medicinal products .
In the Directive it is stated that the Committee shall draw up its own
Rules of Procedt-re . The Council adopted at the same tirce as the IMrective
e declaration according to which " the Commission s !iall si/ bmit to the
Council the draft Rules of Procedure . Subject to the observation it may
formulate , the Council takes notice cf the draft , the adoption of which
is agreed to by the Comissiori and the Member States" ( doc . 643/ 75
(RP/CRS 16) of ?C July 197S). |
The attached draft Rules of Procedure have been agreed to by the repre­
sentatives of the f-ienber States in the Committee .
 ---pagebreak---                           Draft Rules of Procédure
                                    of the
                Committee for Proprietary Medicinal Products
 HIE COMMITTEE R)R PROPRIETARY MEDICINAL PRODUCTS,
 Having regard to Council Direotive 75/319/EBC of 20 May 1975 on the approxi­
 mation of provisions laid down "by law, regulation or administrative action
 relating to proprietary medicinal products ( 1 ), and in particular Article 8 ( 3 )
 thereof,
 HAS       UP ITS RULES OP PROCEDURE AG FOLLOWS :
                                                                     • • •/• • •
1 OJ N° I 147, 9.6.75/ P-
 ---pagebreak---                                   Article 1
1 . The Committee shall consist of one representative for each Member State
    and one representative of the Commission. One alternate shall be appointed
    for each of the representatives.
2« The Committee members and the alternates shall be appointed by the Member
    States for three years provided they continue to be national officials
    responsible for examining applications for authorization to market proprietary
    medicinal products. Their appointments shall be renewable.
3. An alternate shall sit ' as such         ' on the Committee only if the full
    member is absent or is unable to discharge his duties.
4. Each representative may be accompanied at Committee meetings
    by not more than three everts.
5. Even after their duties have ceased, members , alternates and experts shall
    be required not to disclose information of the kind Covered by the obliga­
    tion of professional seorecy.
                                  Article 2 '
The Committee shall elect its Chairman from among its members by absolute
majority and secret ballot. If, after two ballots , no candidate has obtained an
absolute majority of the votes , the member who obtains the relative majority
at the third ballot shall be elected. In the event of a tie the oldeet candidate
shall be declared elected.                      ^    ■          >
                                                             /            . »
                                  Article 3
The term of office of the Chairman shall be three years. He shall be eligible
for re-election once only.
 ---pagebreak---       t
                                         Articlo 4 "
           i                 ■                                 ■             •
 On taking up hij^duties , the Chairman shall cease to be a represen­
 tative and shall be replaced in "that capacity*
                                                                       %
                                         Articlo 5
Two Deputy Chairmen shall he appointed to replace the Chairman when he is
absent or unit.le to discharge his duties® One shall "be elected "by the Committee
and the other appointed "by the Commission,
                                                            .
The provisions of Articles 2 and 3 of these Rules of Procedure shall apply to
the election and the terra of office of the elected Deputy Chairman.
                                        Article 6
The Committee shall be convened by its Chairman, either on his own initiative
or at the request of a member#                                             •
                                        Article 7
The Chairman shall draw up the agenda,             which shall distinguish
betveon :
( a) objections to applications for marketing authorizations submitted to the
     Committee for an opinion under Article 11 (l) of Directive 7f/3l9/EEC{
(b) rofus.-als , suspensions or revocations of marketing authorizations submitted
     to -Ihe Coirisitfcee for an Opinion under Article 12 (2) of Directive 7^319/EBCj
(c) fresh exanirmtions of previous opinions under1 Article 13 of Directive
     7V -.19/ HIIX'Î .                           .. .
                                           : : :      «.
(d) rpocific ; cases s.«iibmit ted trader Article 14 of Directive 7^/319/EEC.
 ---pagebreak---                                      Article 8
Requests to convene the Committee which are made by a member shall be drawn up
in accordance with the classification       in thej, foregoing Article and
reasoned     so ' that they may constitute the working paper of the Committee.
                                     Article y
1« Fursiwnt to Article 9 (l) of Directive 15/^9/ EEC , the Member State con­
   cerned shall forward to the Committee a dossier containing s
   ( a) a copy of the request for forwarding to the Competent authorities of
         thr* Ilember States specified;
   (b) c. copy of the marketing authorization;
   ( c) tho particulars and documents specified in the second paragraph of Article
         4 of Directive 65/65/EEC.
   There shall be forwarded as many dossiers as there are Member States
   specified, plus one for the secretariat of the Committee,,
2» Pursuant to Article 9 ( 2) of Directive 75/319/ESC » the Committee shall
   forthwith forward this dossier to the competent authorities of the Member
   States specified,
3. The Committee shall forward to the                of the Coraiatt^e thd dccGments
    referred to in paragraph 1(a ) and Ob).
                                     Article 10
lo The particulars and documents referred to in points ( 1 ) to ( 7 ) and ( 9 ) to ( 11 ) of
    the second paragraph of Article 4 of Directive 65/65/ EEC shall be provided
     in the official language or one of the official languages of each of the Member
    States specified . The particulars and documents referred to in point ( 8 ) of the
     second paraaraph of Article 4 of the said Directive may be provides in a language
    acceptable to the Member State specified .
 ---pagebreak---                                           - 5 «
  2 . The particulars and documents specified in the second paragraph of Article 4
       of Directive 65/65/EEC and intended to be preserved by the secretariat of
       the Committee shall be provided in a language acceptable to the Committee .
  3® TIi a d.-s3ioJ:4 preserved by the secretariat of the Committee may be consulted
      "by any member of the Committee or by the experts referred to in Article
       1 ( 4 ) with the written authority of the member .
                                        Article 11
 1 . The notice convening the meeting , the agenda and the working papers shall
      be forwarded by the Chairman to the members of the Committee in accordance
     with the prrcrdv-rs laid down in Article 18 (2 ) and (3 ),
 2. These papers shall be drawn up in a language acceptable to the Committed .
 3* These papers shall be dslivered to the Permanent Representatives of the
     Member States and to the Commission not later than fifteen days before
     the d-.t'a' of -'.he meeting .
                                                                                      /
4® In urgent cases , the Chsiraan may, at the request of a member of the
     Committee or on 'his own initiative, shorten this period of notice by up
   . to three clear working days , stating the grounds for his decision .
                                       Article 12
1 . There shall be a quorum at meetings of the 'Committee if six Member States are
     represented .
2 . The ropreseniatiTO pf a Member State may, if necessary, act as the '
     representative of one other Member State . The Chairman of the Committee
      shal l be informed accordingly "by the PerKanent Representative of the
     Member State who is to be so represented .                           .-
                                                                          » ê #/# o «
 ---pagebreak---                                         - 6 -
                                       Article 13
    The Committee may set up panels of experts to Btudy matters of common
    interest «
    The secretarial services for the Committee shall be provided by the Commission^
    assisted , if necessary, by experts .
                                       Article 15
• 1# The Member States concerned shall be informed forthwith of the reasoned opinions ,
        delivered under Articles 11 and 12 of Directive 75/319/^®^ ™
        accordance with the procedure set out in the first subparagraph of Article
  ,     18 (2 ).
    2 . Minutes shall be prepared under the responsibi lity of the Chairman                   .
         for each meeting ; they  shall be forwarded to the members of the Committoe
        in accordance with the procedure set out in Artiole 18 (2 ) and ( 3 ). Any
        comments which the members may wish to make shall be communicated to the
        Chairman in writing . The Chairman shall pass them on to the Committee j
        if there is disagreement } the proposed amendment shall be discussed at
        the following meeting. If disagreement persists , this amendment shall be
        appended to the relevant minutes .
                                       Article 16
    The Chairman of the Committee shall act on behalf of the Committee for the purpose
    of making the formal record referred to in Article 10 ( 1 ) of Directive 75 / 319 / EEC .
    He shall forthwith inform the , Member States concerned of such formal record
    in accordance with the procedure set out in the first subparagraph of
    Article 18 (2 )«                                   .
                                                                             • • •/C
 ---pagebreak---                                           Article 17
  1 » The secretariat of the Committee shall act on behaljf of the Committee for the PUTDOS
       of forwarding the dossier referred to in Article 9 ( 2) to the competent authori­
      ties ni* t.v.s lOThar Stages in accordance with "the procedure set out in the
       first subparagraph of Article 18 ( 2) and, for the purpose of forwarding the document
      x-etarrod to in Article 9 (3 ).                                                ,
  2 . Any information forwarded to the Committee in accordance with Articles
      11 ( 3 ) f 12 M and 33 of Directive 75/319/EEC shall be brought to the
      knowledf^ of "the ff'-itnbers of the Commit tee by the secretariat in accordance
      with the proooSure set out in the second subparagraph of Article 18 ( 2 ).
                                          Article 18
 1 „ Correspondence concerning the Committee shall be addressed to the secretariat
      of the Committee , Direct orate-General for the Internal Market , for the
      attention of the Chairrnan .
 2 . Cor^cnior^taice intended for the representatives of the Member States shall
     be adireese& to the Permanent Representatives .
     Copies of such correspondence shall be addressed directly to the represen­
     tatives of the Member States .
 3 . Correspondence intended for the represent at ive of the Commission shall be
     addros.^el *0 the Coranission , Directorate-General for the Internal Market .
                                         Article 19
 Notwithstanding Article 214 of the TreatyV the work of the                            ~~ "* ,
 Committee and of the panels of experts and all the documents submitted to them
 shall be treated as confidential . Nevertheless f the representatives of the                '
Membor 3+ art03 may, in accordance with the national laws in force, inform the
person ro.:- norisible for marketing a medicinal product or products of the                  *
reasoned object : on of a JTamber "Stat®, as referred to in Artiole 10 (2 ) of
Directive 75/319 £ec*
 ---pagebreak---                              Financia t Tocoro Sheet
The Committee cn Proprietary ; Icci ci na I Products in ccnpGsed fcy represen­
tatives of the Membrr States and cf the Commission .
                          t
The Committee wilt meet in the following cases :
                           »
• when it is wanted to rarket the product in at least five Member States
   other than the first fierher State hevinp authorized the product
- wh<9n Member States have tafcer different decisions regarding the same
   product
- When in specific c«ses » Berber St£to£ £sk fof ths opinion of the Committee
   before reaching e decision concerning a rarketinr; authorization
It is nat possible to predict «nything enact about the fr^ouency of the
meetings' O'f the iommitteje beceusc it ^epentfs cn manufacturers and Mer.ber
                           !
States to what extent the Comity ttee-procecurc uilt be user!. However , taking
into account the time-limits which shatl be followed fcy the Committer? when
a case is brought fcr it? it wgultf be recscrabte to estimate the annual
                           i .                           %
number of meetings to twelve . Every Nenfctr State maj senc? a deleaation.
with 4 Members        ^cfinistf^tor^ fne .analyst* civ> pherfrfltoto&ist «nd» .
one clinician) t<v lUtS'n^tinos^
                          f     -
                                    Thi:y- kill
                                           .  -
                                                Gnly
                                                  -r
                                                     bo pa1£ ifi* .tfav^U*
                                                                    - . *
                                                                           costs
from the commission.      *                                            ■ •
Under the mentioned- suppositions the costs fcr the Ccmrcis&ton will be
around 2$0.0G0 FB.per noting of enr.uaIly $»t)Dp.0G€ Fts.               •