No Waiving of Registration Requirements of Drugs

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By: Kebba AF Touray

The Executive Director of the Medicine Control Agency (MCA), Markieur Janneh Kaira, has debunked claims that the Agency is going to waive the registration requirements of products.

She said this during her appearance before the legislative Select Committee on Health for a discussion on the mandatory testing of drugs imported and listing of drugs from the UK.

“That’s clearly not true. MCA has never said they will waive registration of products no matter where they are coming from. What we said was that we will try to see how to implement it,” she clarifies. She recalled that during their meeting in which the President was in attendance, she made it clear that they cannot negotiate registration, saying “registration is a key mandatory requirement in the Act and no country waives registration because of the country of origin, what we could try is to probably reduce the documentation requirements so that they will be able to comply”.

According to the Executive Director, the other issue was how to provide a certificate of analysis for products coming from SRAs such as in Europe, UK among others, and they had discussed and agreed that they will in the meantime accept some other documentation like the MHRA.

“When it comes from the UK, some certificate of conformity and other documentation that may support the origin of the product will be considered to see its authenticity,” she said.

On registration of products, she said they clearly tried to communicate on the requirements for registration which is still in force and they are not going to negotiate that; adding that it is just a means to encourage them to be increasing and identifying the products that they want to be registering.

She said listing is an alternative to give the importers time to sort themselves out, because of the capacity challenge and for the MCA to know what is in the country.

“This listing is also in force and we initially said products should be listed annually and they wrote to say that that is a challenge because of financing. So, we said as of 2019 or 2020 if you listed it before we will waive the requirements,” she said.

She said communication is in the pipeline to show all importers that all the products that have been listed before with effect from earlier, will be deemed as expired and they have to list these products that are tentatively a problem in terms of getting registration documents.

“We will not accept any new product for listing. If you want to bring a new product into this country it has to be registered. We have equally been concerned about the way forward and how we are going to implement the regulatory requirements in the meantime in consideration of the importers to also make sure that we do not stifle the supply chain. MCA with support from the board through the Ministry will not condone that. We see how best we give them time to be getting products that they can register. But requesting that we get the products from the UK and we will not register it is not a reasonable request and it cannot be entertained,” she told the committee.