Import License Application

KENYA,  GHANA, NIGERIA and UGANDA:

 

• Generally, the process in Africa is that the CTA applies for the IL. This is normally the sponsor, due to them generally not having a registered entity in the country they delegate this responsibility to the site. The site however doesn’t always have the knowledge or time to obtain the IL. MERCLINCO steps in to obtain the IL.
• Once we receive a Letter of Delegated Authority provided by Sponsor the process is initiated.
• The IDF and PPB will be submitted for approval upon the green light approval check.
• General timelines in Africa is 14-21 working days depending on the country for IL application.
• Accredited ‘in-country’ Expert Regulatory Vendor prepare the necessary documentation and submits the application to HA’s.
• MERCLINCO’s in-country regulatory experts facilitate this process and rapidly crunch these timelines.
• We experience IL approval in about 5-7 working days. (Countries except Kenya.)
• In Kenya we do the IDF and PPB in 24-48H.
• In Kenya: ONE Import licence application is performed for ALL SITES for entire duration of study. No need to apply for individual sites nor at regular intervals.

 

SOUTH AFRICA:

• The timelines for approval has seen drastic and unprecedented improvements from, in some instances,  >12 months to 3 to 4 weeks.

 

 

MECLINCO also offers other end-to-end solutions for conducting clinical trials in these countries – from regulatory submissions to logistics, recruitment, quality assurance, study source docs +++.