This is an HTML version of an attachment to the Freedom of Information request 'DG SANTE contacts with industry re. Supplementary Protection Certificates (SPCs) manufacturing waiver'.




 
Ref. Ares(2018)5814787 - 14/11/2018
EUROPEAN COMMISSION 
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY 
 
Health systems, medical products and innovation 
  Medicines: policy, authorisation and monitoring 
Head of Unit 
Brussels,  
SANTE/B5/AL/mmc 
 
By email only 
 
 
Dear Ms Tansey, 
Subject: 
Your application for access to documents – Ref GestDem No 
GESTDEM 2018/5418 

We refer to your email of 12/10/2018 in which you make a request for access to 
documents, registered under the above-mentioned reference number. 
Your application is currently being handled. However, we were not in a position to 
complete the handling of your application within the time limit of 15 working days, 
which expired on 07/11/2018. An extended time limit is needed as part of the documents 
requested originate from third parties, which will be consulted.  
Therefore, we have to extend the time limit with 15 working days in accordance with 
Article 7(3) of Regulation (EC) No 1049/2001 regarding public access to documents. The 
new time limit expires on 28/11/2018. 
Yours faithfully,  
 
Yours sincerely,  
   [Electronically signed]  
 
Olga Solomon 
 
Ms Rachel Tansey 
Corporate Europe Observatory  
Rue d'Edimbourg 26  
1050 Brussels  
Belgium 
Email : xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxx.xxx  
 
 
 
Commission européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel - Belgium. Telephone: (32-2) 299 11 11. 
E-mail: xxxxxxxxxxxxxxxxxxxxxxxx@xx.xxxxxx.xx 
  
 
 
Electronically signed on 14/11/2018 07:47 (UTC+01) in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563