Coordinated Wholesale Centers (CWC)
REGISTRATION AND LICENSING
Procedures and Guidelines
Drug distribution channel is the channel (pathway) through which a drug product moves from the manufacturer and/or importer to the end users. This pathway not only helps in the product tracking, it also helps to monitor and guarantee the product quality, integrity and safety of its use by the end users.
Healthcare services in Nigeria and the world over largely hinge on availability of and access to medicines that are affordable, efficacious, safe, and of good quality.
The process of developing the National Drug Distribution Guideline (NDDG) began in 2009 as a collaborative effort of the Federal Ministry of Health (FMOH), the Presidential Committee on Pharmaceutical Sector Reform (PCPSR) with stakeholders in the pharmaceutical sector. The goal for the development of the NDDG is to achieve a well-ordered drug distribution system in Nigeria. This goal that is yet to be achieved, is one of the key objectives of the National Drug Policy launched in 1990 and revised in 2005.
The launching of this document (NDDG) by the then Honourable Minister of Health in 2012 signaled the take-off of its implementation while deadline for the establishment of State Drug Distribution Centres (SDDCs) by the State Governments and Mega Drug Distribution Centres (MDDCs) by the Private Sector was issued on June 30, 2014.
This date of implementation was set-aside after series of reviews and consultations with stakeholders. This deadline was, however, extended to June 30, 2015 through a Ministerial Directive on June 26, 2014 to allow more time for the establishment of enough SDDCs and MDDCs.
As the deadline of June 30, 2015 drew near, the Permanent Secretary, Federal Ministry of Health addressed a Press Conference on June 26, 2015 during which he directed the regulatory agencies, that is, the Pharmacists Council of Nigeria (PCN) and the National Agency for Food and Drug Administration Control (NAFDAC) to commence the enforcement of the mandate to ensure full compliance with the NDDG by all concerned with effect from July 1, 2015.
However, having been cognizant of the need for adequacy of regulatory instruments and the need for political will for enforcement of these instruments, the Food and Drugs Department of FMOH, PCN and NAFDAC saw the need to take full advantage of the policy and the current political will behind to make history by ensuring that the foundation for evolving a sound drug distribution channel is established and vigorously pursued in Nigeria.
Despite the series of events above, there were protests to the press release by some stakeholders. This prompted the Pharmacists Council of Nigeria along with NAFDAC and FMOH to effectively engage these stakeholders to critically examine their grievances and find a way forward.
After extensive deliberations, certain recommendations were made as amendment to the earlier concept on MDDCs and SDDCs. These include:
- The open drug market operators have become stakeholders in the distribution of medicines in Nigeria and there is need to create a conducive environment to enhance their regulation.
- The NDDG as approved by the FMOH is commendable. However, the stakeholders in the open drug markets who were not considered in the earlier concept should be accommodated and be relocated to coordinated wholesale centres (CWCs).
- The CWCs shall operate as wholesale centres within the Drug Distribution Network.
- Similarly, the stand-alone wholesalers are to be clearly placed in the new flow chart at the same level with CWC.
- These recommendations as well as a proposed framework of implementation were forwarded for the consideration and approval of FMOH, which was granted by the Permanent Secretary; vide his letter dated August 3, 2015.
- The centre shall be managed by a withholding company which shall register it with the PCN.
- The centre shall have one superintendent pharmacist .who shall have not less than fifteen years’ experience.
- Registration fee for each CWC shall be determined by the PCN
- Premises within the centre shall have full time pharmacists who shall be distribution managers.. A distribution manager shall coordinate activities in not more than five premises within the Centre.
- The distribution manager shall be employed by the withholding company on behalf of the premises in the centre while the clerical staff and attendants are employed directly by the premises
- The withholding company shall be responsible for the maintenance of the centre
- The wholesale centre shall sign a memorandum of understanding with the withholding company
- Provision shall be made for office of inspectors from Pharmacists Council of Nigeria National Agency for food and Drug Administration and Control (NAFDAC) and a police post
- There shall be warehouses within the coordinated wholesale centres that feed the premises
2. Number of premises in the wholesale Centre
Coordinated wholesale centres shall have not less than 200 premises
3. Street Trading:
- There shall not be street trading within the coordinated wholesale centres
- All the walkways within the coordinated wholesale centres shall be free.
4. Scope of Products
- The wholesale centres shall be solely dedicated to the sale of medicines. However Provision shall be made for food vendors and banks
5. Documentation for Registration of Coordinated Wholesale Centres
All applicants for the registration of Coordinated Wholesale Centre(s) (CWCs) shall submit to the Registrar, Pharmacists Council of Nigeria the following documents:
- Application letter to register the centre;
- Duly filled Form B (PCN Application form for registration of premises);
- Photocopy of annual licence to practice/application for retention of name on the Pharmaceutical Register (Form J);
- Evidence of payment of prescribed inspection and registration fees paid to the Pharmacists Council of Nigeria;
- Photocopy of letter of resignation from previous employment (if applicable);
- Letter of acceptance of resignation (if applicable);
- Letter of appointment in the centre where applicable;
- Legal agreement between the Superintendent Pharmacist and his employer ;
- Company’s Certificate of Incorporation
- Article and Memorandum of Association (Certified True copy);
- Particulars of Directors as issued by Corporate Affairs Commission (CAC) (Certified True copy);
- Photocopy of NYSC Discharge or Exemption Certificate of Superintendent Pharmacist, where applicable;
- Letter of undertaking by the Superintendent Pharmacist to the effect that he has only one full time job;
- Letter of undertaking by the Managing Director of the Company to the effect that all pharmaceutical businesses will be left under the direct, personal control and management of the Superintendent Pharmacist;
- Pharmacists inter-state movement Form (where applicable);
- Evidence of membership of a registered and licenced Pharmacist on the Board of Directors
6. Requirements for Registration of premises in Coordinated Wholesale Centres
- There shall be personnel for Quality Assurance
- There shall be personnel for Inventory Management
b. Storage Facility
- Each storage area should have a minimum area of 70 sqm inclusive of other office apartments
- Minimum Height shall be 3.05 meters
- There shall be a Loading bay/Delivery bay in the centre.
- There shall be at least one quarantine area in the centre
c. Good Storage Practice
- Products shall be properly demarcated.
- There shall be Standard Operating Procedures (SOP)
- There shall be:
- Systems to ensure adequate cooling
- Appropriate cold rooms/refrigerators thermolabile products
- Plastic/treated wooden pallets and metallic racks
- for the storage area
- Temperature and relative humidity logs and log recording equipment
- Good lightening system
- Dust free flooring
- IT enabled inventory management system
- A well dedicated and secured area for controlled substances
- A separate and dedicated area for rejects and returned products as well as retention samples
- Adequate material handling equipment
- Rodent and Insect trappers.