To enhance local production of pharmaceuticals in Nigeria, the Five Plus Five-Year Validity has been reviewed. The following steps will be taken to enforce the policy:
Step 1: At the point of first product registration, companies will be given a statement that foreign manufacturers will be required to either form partnerships with Nigerian companies or/and set up a local manufacturing plants for FPPs, APIs, non-APIs, packaging materials, etc.
Step 2: A product registration license is valid for 5 years and by the end of the 4th year of license validity, companies are required to submit draft blue prints of proposed partnerships with Nigerian companies or/and set up local manufacturing plant.
Step 3: Renewal in Year Five: Upon successful renewal for another 5 years for companies with verifiable blue prints, NAFDAC will monitor the migration of the imported drugs to local production.
Step 4: At the end of Year 7 (First 5 years + 2 years into renewal), if there is no progress on migration to local manufacturing as detailed in the blue print, an alert for de-registration will be sent to the company at the beginning of year 9.
Step 5: For Products that have already enjoyed more than two cycles of renewals, companies are required to submit immediate BLUE print on migration to local manufacturing by December 31st 2019. Full implementation should be accomplished within 4 years of submission of the plan otherwise product will be deregistered.
Where a manufacturer has more than one product, a verifiable blue print for local production of at least one product will be acceptable and allowed.
NOTES: * The migration to local manufacturing will be limited to products the local manufacturers have capacity to produce or that partnership would enhance the capacity to manufacture.
** Not all products may be manufactured locally therefore; there are products that will be imported due to country capacity that has not yet been attained.
