No C 302/6 Official  Journal  of the  European  Communities 15. 12. 77 
Notice  to applicants  for  marketing  authorizations  for  proprietary  medicinal  products 
I. A new  procedure  for placing  proprietary  medicinal  products  on the market 
Following  the European  Community  Directives  adopted  in 1975  (Official  Journal  of 
the European  Communities  No  L 147  of 9 June  1975)  all manufacturers  of and 
persons  responsible  for  marketing  proprietary  medicinal  products  may  now  use  a 
new procedure  for  placing  their  products  on the  markets  of the  Member  States: 
they may  go through  the  Committee  for  Proprietary  Medicinal  Products  attached 
to the Commission  of the European  Communities  in Brussels. 
II. Conditions  to be fulfilled  in order  to use this  procedure: 
1. The  proprietary  medicinal  product  in question  must  first  have  obtained  a 
marketing  authorization  (subsequently  referred  to as M.A.)  in one  of the 
Member  States,  as laid  down  in Directives  65/65/EEC,  75/318/EEC  and 
75/319/EEC. 
Vaccines,  toxins  and  serums,  proprietary  medicinal  products  based  on human 
blood  or blood  constituents,  radioactive  isotopes  and  homeopathic  proprietary 
medicinal  products  may  not  benefit  from  this  procedure  (Article  34 of Directive 
75/319/EEC). 
2. Applications  for  M.A.  via  the  Committee  must  relate  to at least  five  other 
Member  States. 
III. Procedure  to be followed: 
(a) Documents  to be supplied  to the  competent  authority  of the  Member  State 
which  has  granted  the initial  M.A.: 
1. Request  that  the  documents  be forwarded  to at least  five  named  Member 
States  through  the Committee  for Proprietary  Medicinal  Products; 
2. Information  and  documents  listed  in the  second  paragraph  of Article  4 of 
Directive  65/65/EEC; 
3. Copy  of the M.A. 
(b) The  number  of copies  of these  documents  to be supplied  is one  for  each 
Member  State  concerned  plus  one  for the Committee  secretariat. 
(c) The  languages  in which  the documents  must  be presented: 
1. The  documents  referred  to in the second  paragraph  of Article  4 of Directive 
65/65/EEC  must  be provided  in one  of the  official  languages  of each  of the 
Member  States  concerned;  except  that  the  documents  referred  to in item  8 
of the second  paragraph  of Article  4 may,  alternatively,  be presented  in: 
— English  for Germany, 
— English  for Belgium, 
— English,  French  or German  for Denmark, 
— English  or French  for  Italy, 
— Dutch,  English,  German  or Italian  for Luxembourg, 
— English,  French  or German  for the Netherlands. 
15.12.  77 Official  Journal  of the  European  Communities No C 302/7 
2. The  copy  intended  for  the  Committee  secretariat  may  be in English  or 
French. 
(d) No  special  fee is payable  to the Committee  for Proprietary  Medicinal  Products, 
but national  registration  fees  remain  applicable. 
(e) A reasoned  opinion  of the  Committee,  which  will  be based  on information 
contained  in the application  for an M.A.,  shall  not  be regarded  as an M.A.  in 
any Member  State. 
IV. Consideration  of divergent  decisions: 
Directive  75/319/EEC  also  makes  provision  for  consideration  by the  Committee 
of divergent  decisions  taken  by the Member  States  as regards  the authorization, 
suspension  or revocation  of an M.A. 
Any one  of the Member  States  concerned  may  request  the opinion  of the Committee 
concerning  the grounds  for refusal,  suspension  or revocation  of the M.A.  as given 
by the authorities  of another  Member  State. 
Within  30 days,  the Member  States  shall  notify  the Committee  of the action  they 
intend  to take  following  the opinion. 
V. Force  of the opinions  of the Committee: 
The opinions  of the Committee  shall  not  be binding  on Member  States  and  shall 
not replace  national  decisions. 
VI. Additional  information: 
For additional  information,  please  apply  to the  Secretariat,  Committee  for  Pro-
prietary  Medicinal  Products,  3 Rond-Point  Schuman,  B-1049  Brussels;  or to the 
appropriate  national  licensing  authority. 
Communication  from  the  Commission  under  Article  5 (5)  of Council  Decision 
75/210/EEC  of 27 March  1975 
By virtue  of Article  4 (4) of Council  Decision  75/210/EEC  of 27 March  1975  on 
unilateral  import  arrangements  in respect  of State-trading  countries  (*), the Commission 
has adopted  the  following  change  to the  import  arrangements  applied  in Italy  with 
regard  to Bulgaria  with  effect  from  28 November  1977: 
— exceptional  opening  of an additional  quota  for the importation  of Lit 25 million  for 
silk-worm  cocoons  suitable  for reeling  (CCT  heading  No 50.01). 
(») OJ No L 99, 21. 4. 1975,  p. 7.