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NDA Launches 2017 professional guidelines (Licensing)

Monday, 12th December 2016

NDA LAUNCHES 2017 PROFESSIONAL GUIDELINES (LICENSING)  

National Drug Authority (NDA) is a government statutory agency responsible for regulating human and veterinary medicines to ensure they are of safe efficacious and of good quality. This is achieved through registration of medicines, inspection of manufacturing facilities, pharmacies and drug shops, laboratory testing of medicines, and monitoring of adverse reactions.   

One of the quality assurance measures that NDA has to fulfill its mandate is the licensing of pharmacies and drug shops. Licenses are issued annually following inspection for suitability of premises.  In 2017: 

  • Licenses will be issued on or before January 31 2017 
  • Pharmacies that are not licensed are expected to close by February 1 2017 

In this new licensing cycle specific attention is going to be paid to pharmacy wholesalers for both human and veterinary medicines who will be required to implement NDA Good Distribution Practice Guidelines 2017 which place emphasis on personnel, documentation and premises.   

Regarding premises 

  • Premises are to be of sufficient space 

            a) The premises shall have sufficient space to avoid overcrowding of customers and staff.

            b) The premises shall be well lit, ventilated and secure. 

             c) The minimum floor area acceptable for pharmacies is:  

  • 41 square meters for wholesales pharmacies (at least 16m2 continuous shop area and 25m2 for storage area). 
  • Premises with dual licenses must meet the minimum floor space requirement of 61m2 in addition to other requirements for suitability of premises. The shop areas for wholesale shall be separate from that for retail; 16m2 for wholesale and 20m2 for retail.  
  •  Administrative area.There shall be a separate office or administrative area, with a full view of the sales area, for the pharmacist and the prescriptions, purchase records and other administrative records shall be maintained in this office or area.  

Regarding Personnel 

Wholesalers are required to employ a pharmacist and professional auxiliary staff including a storekeeper  
  
Regarding Documentation 
  • Wholesalers must be able to track and trace each item they sale. i.e. the origin of the product and the entity to whom they have sold to. Records must be available on the premises where the transactions occur and available for inspection at all times.   
Display of Products 
  • Wholesale pharmacies are also not expected to display the medicines and medical product on sale  

Other changes instituted in the 2017 licensing guidelines expected to help improve the regulation of medicines in the country, increase access to underserved areas and also reduce the time taken to process licenses include: 

  • Establishment of an electronic system for processing licenses as a first step toward full automation of business processes and improving service delivery. 
  • All pharmacies are expected to destroy any expired or damaged medicines prior to application for their annual license 
  • Pharmacies stocking products that require a cold chain e.g. veterinary vaccines must have appropriate equipment and effective monitoring systems 
  • Retail pharmacies are expected to keep detailed records of all medicines that they sell including batch numbers and expiry dates for traceability   

NDA wishes to inform the public to buy medicines from licensed pharmacies and drug shops to ensure that they are protected from poor quality, unsafe and ineffective products.  

To report poor quality medical products, non compliance, fraud or complaints please call NDA free toll free 0800101999