In July 2018 the National Agency for Food and Drug Administration and Control (NAFDAC) in partnership with Clinton Health Access Initiative published draft Guidelines for Procurement and Management of a Mobile Authentication Service (MAS) scheme (the Guidelines). The guidelines comes 8 years after NAFDAC deployed the MAS scheme in 2010 with the aim of curbing counterfeit practices and to detect substandard and falsified medical products. The scheme employs the use of scratch codes and Short Messaging Service (SMS) to verify the authenticity of medical product at the point of purchase. Following the success of the pilot, NAFDAC deployed the MAS Scheme in January 2012, against anti-malarial and antibiotic medicines imported or manufactured in Nigeria. However, despite the innovation, there were challenges in effectively implementing the scheme and the House of Representatives raised concerns about the implementation and application to all drugs purchased in Nigeria. The introduction of the 2018 MAS guidelines is thus a major development and serves as a strategy to ensure that the scheme is effectively implemented and enforced by stakeholders.1
The following are key provisions in the guidelines:
1. APPROVED MAS PROVIDERS AND THEIR CORRESPONDING SHORT CODES
The guideline outlines the five approved MAS providers authorised to offer MAS technology to Holders of Certificate of Registration (HCR) and their corresponding codes. This information is relevant to consumers and the public to make it easy to identify the recognised HCRs and their respective short codes.
2. ENROLLING REGISTERED PRODUCTS ON THE MAS SCHEME
The guideline enumerates the procedure required to enroll and renew medical products registered with NAFDAC on the scheme.
2.1 HCRs/Holders of notification of registered products that need to deploy the products on the MAS scheme are required to approach any of the approved MAS providers listed in the guideline and the MAS provider would then verify the registration status of such product(s) from NAFDAC. A Notification Form should be completed by the HCRs or Holders of Notification and sent to NAFDAC.
2.2 From January 1st 2018, the guidelines provide that applicants will require the MAS standard notification form as one of the requirements for license renewal of the approved medical products which include:
Antiprotozoal Drugs –
- Antimalaria drugs (All antimalarial drugs including sulphadoxinepyrimethamine (SP) and injectables.
- Antiamoebic, antiglardial and antitrichomonal drugs (metronidazole formulations only infusions, tablets and suspensions).
Antibacterial Drugs –
- Beta-lactam drugs
- Other beta-lactam antibacterials
Other antibacterials –
- Sulfonamides and trimethoprim
To switch from one MAS Provider to another, the guideline provides that MAS providers are mandated to send a letter of intent and a detailed transition plan to NAFDAC which will only be approved after due consideration and implementation of the transition plan. The guideline also provides that where any issue arises from agreements between MAS Providers and HCRs in the implementation of the MAS scheme, complaints should be directed to NAFDAC.
4. MINIMUM STANDARDS FOR QUALITY OF SERVICE FROM MAS PROVIDERS
The guideline provides the minimum standards required of every NAFDAC approved MAS provider regarding registration, certifications, short messaging systems, verification channels, database management and market intelligence. Some of the requirements are as follows:
4.1 MAS providers must be a registered company in Nigeria and must have an established and verifiable data quality management and data security system.
4.2 SMS responses for confirmed products shall contain the product name, NAFDAC registration number, the product expiry date, the product batch number and helpline for further information and/or reports of suspected product.
4.3 MAS providers shall offer verification through SMS, and must provide 24-hour call services as a backup verification channel in addition to SMS, using a local phone number for ease of access.
4.4 MAS providers shall provide NAFDAC access to information on locations of potentially counterfeit products, and any other information relevant to the regulatory activities of the Agency.
4.5 HCRs and MAS providers shall provide the Agency with data and/or information on all products under the MAS scheme which will be managed by NAFDAC.
4.6 NAFDAC in collaboration with the MAS providers will maintain the framework for Monitoring & Evaluation (M&E) of the scheme. NAFDAC shall audit all MAS providers periodically to ensure adherence to set minimum quality standards.
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* Oluwasolape Owoyemi and Bisola Scott, Associates Intellectual Property & Technology SPA Ajibade & Co.
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