Wednesday, 29 January 2020
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Opening pharmaceutical enterprises

I. License procedure in the pharmaceutical area

1.1. Administrative formalities for opening a pharmaceutical establishment

  • Request for implantation notice to the provincial inspector pharmacist ;
  • The inspector pharmacist applies to the pharmacists’ association, opinion on the regularity of the applicant pharmacist ;
  • In view of the opinion of the pharmacists, the inspector pharmacist makes a report of the site visit and that of the implantation opinion ; If the opinion is favorable ;
  • The applicant writes to the Minister of Health to request the opening of authorization in 4 copies, the 4 copies are put in 4 files which will contain the following :
Pharmacist file :

- Pharmacist’s degree ; 
- Operating certificate for a pharmacy (Association of Pharmacists) ; 
- Certification of taking responsibility (DPM) ; 
- Information individual form on the pharmacist (DPM) ; 
- Labor contract duly signed and stamped by the labor inspection and / or Synaphaco.

  • R.C.C.M. n°
  • National Identity n°
  • Company status
  • Technical investment file
  • Sketch within the institution
2nd pharmacist file :
  • Pharmacist’s degree ;
  • Operating certificate for a pharmacy (Association of Pharmacists) ;
  • Labor contract duly signed and stamped by the labor inspection and / or Synaphaco.
File of assistant in pharmacy :
  • Photocopy of Diploma ;
  • Green Card ;
  • List of pharmacopoeia, vidal, libraries or texts (scientific literature) ;
3rd Department
  1. Deposit finding of PV places in the 3rd direction (if these are favorable PV) ;
  2. Letter of invitation to the payment for opening tax ;
  3. Authorization to open a tax wholesale house ($ 3000) ;
  4. Once the tax paid, the 3rd Directorate is the project of opening authorization for signature of the Minister of Health via the General Secretariat.

1.2. Technical formalities

1. Have an appropriate local

a. Pharmacy

House made of durable materials, provided with ceiling, electrified, with an area of 45 m², comprising at least 4 rooms including :

  • Hall of delivery ;
  • Storage room + laboratory ;
  • Pharmacist’s office ;
  • Sanitary facilities.
Conservation means
  • Proper conditioning ;
  • Refrigerator ;
  • Metal stands or lacquered wood and cupboards.
b. Wholesale house

House made of durable materials, provided with ceiling, electrified, with an area of 150 m², comprising at least 5 rooms including :

  • Waiting room and delivery ;
  • Storage room ;
  • Pharmacist’s office ;
  • Secretariat and accounting ;
  • Sanitary facilities with running water.
Conservation means
  • Proper conditioning ;
  • Refrigerator (air conditioning) ;
  • Metal stands or lacquered wood and cupboards ;
  • Wood pallets for products ;
  • Temperature 22 ° C, relative humidity at 60%
c. Manufacturing laboratory

House made of durable materials, provided with ceiling, electrified, with an area of 180 m², comprising at least 8 rooms including :

  • Quarantine room of raw materials ;
  • Storage room of raw materials after analysis ;
  • Preparation room and of packaging ;
  • Hall of analysis and sample library ;
  • Delivery room ;
  • Pharmacist’s office ;
  • Administration (secretarial and management) ;
  • Sanitary facilities with running water ;
  • Conservation means (see wholesale house).

1. Be pharmacist or have a pharmacist registered in the pharmacists’ association ;

2. Request for implantation opinion to be sent to the provincial inspector pharmacist with a copy to the Department of Pharmacy.

3. Pharmacist’s file :

  • Pharmacy degree ;
  • Operating certificate for a pharmacy (Association of Pharmacists) ;
  • Certificate for taking over responsibility ;
  • Information individual form on the pharmacist ;
  • Labor contract duly signed and stamped by the labor inspection and / or Synaphaco.

4. Pharmacy assistant file

  • Diploma + green card + contract

5. Other elements of the file :

  • Opening authorization application to the Minister of Public Health ;
  • NRC ;
  • National identification number ;
  • Interior sketches ;
  • Technical investment file ;
  • List of staff concerned with medicines ;
  • Statutes (if a company).

6. Have a minutes’ finding of the places established by the provincial inspector pharmacist in accordance with current standards.

7. Present a report prepared by the re-survey Committee.

8. Having paid the administrative fee for the type of establishment concerned.

NB : In addition to the criteria defined above, expatriates can only be authorized for production laboratories or when they are importing drugs, provided they have a good conduct certificate issued by the respective embassies.

1.3. Authorization to market drugs.

For permission to develop the drug market, the applicant must :

  • have his own pharmaceutical establishment ;
  • contact existing EVG or local scientific representation houses ;
  • constitute a complete technical file, CTD model including the administrative file, pharmaceutical, pharmacological, toxicological, clinical, analytical and microbiological ;
  • have 50 selling model samples available. More than 50 samples for the content under 5 units ;
  • have 25 samples ready for renewal. Over 25 samples for the content under 5 units ;
  • Present the following items :
    • an appropriate registration form in triplicate (10 000 CDF) ;
    • G.M.P. certificate of the Manufacturing laboratory ;
    • A.M.M. issued by the country of origin ;
    • Representative contract signed with the manufacturing laboratory ;
    • a local analysis report per product ;
    • products selected for evaluation ($ 75 / product) ;
    • products eligible for obtaining provisional marketing authorization (one year) $ 250/product ;
    • products eligible for obtaining quinquennial marketing authorization (five years) $300/product ;

Other conditions :

  • Inspection visit of the production site by the drug regulatory authority (ARP) for any new laboratory under the responsibility of this one (a team of three inspectors) ;
  • Marketing : public or private ;
  • Distributors : public or private.

N.B. As for the five-year authorization for the market, it will be granted after clinical, psycho-chemical and physico-chemical evaluations to be conducted by the Department of Pharmacy and Medicine. The costs of different expertise required are your responsibility. Also, you would be informed in time by our services of the rates charged by our approved experts.

II. Reception sheet of application files for the marketing authorization cf. Decree N°1250/CAB/MIN/S/01/D/2000 of 14 March 2000

File components to be submitted Yes No
1 Letter applying for permit to market(AMM) (temporary or renewal)    
2 For applicant/local representative : 
- Physical address ;
- E-mail
- Telephone
3 Ad hoc completed form and signed (5 copies)    
4 Document evidencing the regular operating of the Ets    
5 Technical file of the product (3 copies)    
6 A contract between the applicant and the manufacturer    
7 Summary of characteristics of RCP product (5 copies)    
8 Valid AMM from the country of origin or CCP (Certificate of the pharmaceutical product)    
9 Valid GMP certificate from the manufacturing laboratory    
10 1. AMM 1 year (temporary)    
  • 50 samples sales models (tablets, bottles, drops, suspension, tubes, pots, etc) ;
  • 4 boxes/1000 tablets ;
  • 4 boxes/100 ampoules ;
  • 10 boxes/10x10 tablets.
2. AMM 5 years (renewal)
  • 25 samples sales models (tablets, bottles, drops, suspension, tubes, pots, etc) ;
  • 2 boxes/1000 tablets ;
  • 2 boxes/100 ampoules ;
  • 5 boxes/10x10 tablets

Why Invest In DR Congo ?

Anapi Financial Times



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