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Country overview: CAMEROON

Cameroon is a central African country having French as official language. Cameroon imports nearly 90% of its needs in medicines. Knowing that the market is estimated at more than 100 billion CFA francs.

Cameroon is part of the Central African Economic and Monetary Community (CEMAC).

Medicines and other health products (such as medical devices) can be imported only after registration.

The registration dossier must be in CTD format and must be in French for some parts. Registration dossier for medical devices is specific to the country.

The authority governing the registration of medicines: Directorate of Pharmacy and Medicines and Laboratories (DPML), website: https://dpml.cm/index.php/en/

 

The registration of drugs depends on the acceptance of the deposit at the level of the DPML and the level of compliance of the file and requires 12 months to 24 months.

AREMA offers you total assistance for the registration of your medicines in Cameroon.

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Country overview: Tunisia

Tunisia is a north African country. The drug market in Tunisia represents nearly 1 billion dollars, with about 47% of imports (under the monopoly of the government through Central Pharmacy of Tunisia) and 53% as local production.

Tunisia's drug registration standards are approaching European standards with a national drug registration guideline.

The registration file must be in CTD format and in French or English language with some parts in French and / or Arabic.

The authority governing the registration of medicines in Tunisia  are: the DPM (Directorate of Pharmacy and Medicine) whose website: http://www.dpm.tn/

Medicine registration in Tunisia requires an appointment through a local and legal representative, upon acceptance of the deposit the assessment is made by the DPM and the LNCM (National Laboratory of Drug Control). It requires 2 to 3 years for registration of the drug in Tunisia.

Medical devices , food supplements and cosmetics are under another specific procedure of AMC (Autorization for consumption).

AREMA offers you full support. For more information : info@arema-international.com

 

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Country overview: Senegal

Senegal is a West African with a coverage of local drug manufacturing of arround 15 % of the market. 

For the registration of Medicines Senegal follows mainly WAEMU and therefore applies its guidelines. In addition, there are some national texts and specificities of the country to know.

The registration dossier must be in CTD format and in French language.

Drug Registration Authority: The DPM (DIRECTORATE FOR PHARMACY, AND DRUGS), whose website: http://www.dirpharm.net/

The registration of drugs depends on the acceptance of deposit from DPM and on the level of compliance of the file and requires 9 months to 24 months and here are main steps:

-Examination of acceptance and deposit at DPM; - Files are sent to the experts; - Files are studied by the experts following a pattern defined by the DPM; - Evaluation reports by experts; - Meeting of the National Commission of Medicine for opinion; - Report from the meeting of the National Drug Commission with the opinions on all applications for Marketing Authorizations for submitted medicines; - Report of the meeting of the National Commission of the Medicine are sent to the cabinet of the Minister in charge of Health; - Preparation of draft orders granting Marketing Authorizations (MA) to be submitted for signature by the Minister of Health. 

 

AREMA offers you total assistance for the registration of your medicines in Senegal.

 

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COUNTRY OVERVIEW: Cote d'Ivoire,, IMPORTANT MARKET AND REGULATORY INFORMATION

Cote d'Ivoire, Abidjan is in West Africa with a population of about 27 million inhabitants, and as an official language French.

Cote d'Ivoire is a member state of the Economic Community of West African States (ECOWAS).

Medicinal products and other health products can only be imported after registration.

An inspection of the manufacturing site of medicinal products is mandatory during the first registrations.

Medicines market in Cote d'Ivoire:

The African market in general is a high-volume import market, in Africa local production accounts for only 3% of world production, while the market is expanding and demand is growing. Cote d'Ivoire imports around 94% of its medicines.

Moreover, introduction of noncommunicable diseases in addition to the major pandemics on the continent, did that the demand for medicines has never been so strong.

Arema offers you the possibility to carry out market studies and field surveys in relation to your products ranges. In addition, AREMA offers you the opportunity to establish the right marketing and distribution way for your products in Cote d'Ivoire.

Registration of medicines:

Cote d'Ivoire is a member of regional institutions, mainly WAEMU and therefore applies its guidelines on the registration of medicines. In addition, there are some national texts and specificities of the country to know.

The registration dossier must be in CTD format and in French language.

The authority governing the registration of medicines is the DPML (Direction of Pharmacy, Medicine and Laboratories) under the supervision of the Ministry of Public Health, whose website: www.dpml.ci

The registration depends on the level of compliance of the file and scheduled commissions, it initially requires to make an appointment for the deposit which will depend on the availability of the authorities then registration will take 12 months to 2 years after the deposit.

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Country overview: Burkina Fasso , important market and regulatory information

Burkina Fasso is a country in West Africa whose capital is Ouagadougou with a population of approximately 20 million, and as official language French.

Burkina Fasso is a member state of the Economic Community of West African States (ECOWAS).

Drugs can only be imported to Burkina Fasso after registration.

 

Medicines market in Burkina Fasso:

The African market in general is a high-volume import market, in Africa local production accounts for only 3% of world production, while the market is expanding and demand is growing. Burkina Fasso has only one manufacturing unit.

Moreover, introduction of noncommunicable diseases in addition to the major pandemics on the continent, did that the demand for medicines has never been so strong.

Arema offers you the possibility to carry out  market studies and field surveys in relation to your products ranges. In addition, AREMA offers you the opportunity to find the right marketing and distribution way for your products in Burkina Faso.

 

Registration of medicines:

Burkina Faso is a member of regional institutions, mainly WAEMU and therefore applies its guidelines on the registration of medicines. In addition, there are some national texts and specificities of the country to know.

The registration dossier must be in CTD format and in French language.

Drug Registration Authority: The DGPML (DIRECTORATE GENERAL FOR PHARMACY, DRUGS AND LABORATORIES), whose website: http://www.dgpml.sante.gov.bf/ 

 

The registration of drugs depends on the level of compliance of the file and requires 9 months to 18 months.

AREMA offers you total assistance for the registration of your medicines in Burkina Fasso.

We provide regulatory services from the regulatory intelligence, preparation and translation of your dossier, the deposit, follow-up and registration of your various products until the establishment of a system of pharmacovigilance and post-marketing monitoring .

 

In order to initiate any collaboration or for any consultation you can contact us by:

• Our contact form: http://www.arema-international.com/contact.php  or

• email: info@arema-international.com  

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New formulation of Carbetocin could save thousands of women’s lives

According to a study published in June 27, 2018, led by WHO in collaboration with MSD for Mothers and Ferring Pharmaceuticals. A new drug formulation of Carbetocin could save thousands of women’s lives

Approximately 70 000 women die every year because of post-partum haemorrhage – increasing the risk that their babies also die within one month.

Currently, WHO recommends oxytocin as the first-choice drug for preventing excessive bleeding after childbirth. Oxytocin, however, must be stored and transported at 2–8 degrees Celsius, which is hard to do, in many countries, depriving many women of access to this lifesaving drug. When they can obtain it, the drug may be less effective because of heat exposure.  

The study, published in the New England Journal of Medicine, has shown an alternative drug – heat-stable carbetocin – to be as safe and effective as oxytocin in preventing postpartum haemorrhage. This new formulation of carbetocin does not require refrigeration and retains its efficacy for at least 3 years stored at 30 degrees celsius and 75% relative humidity.

For more information here is the article: https://www.nejm.org/doi/full/10.1056/NEJMoa1805489

and WHO press release : http://www.who.int/news-room/detail/27-06-2018-who-study-shows-drug-could-save-thousands-of-women%E2%80%99s-lives

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CPP use for Drugs Registration in Africa and Middle east

The Certificate of Pharmaceutical Product (CPP) is a document of the World Health Organization’s (WHO) Certification Scheme on the quality of pharmaceutical products moving in international commerce. CPP also known as CoPP establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country. WHO developed CPP in the late 1960s with the aim to provide assurance to its members about the quality of the pharmaceutical products moving in international trade. The CPP is widely required by emerging countries such as African and middle eastern countries in new drugs’ submission processes, post-approval changes and renewal of drugs’ registrations. Some countries in middle east request its legalization by their embassy in country of origin. CPP is more and more replacing marketing authorization in country of origin in these countries and is accurately checked by health authorities as a reference document for drug approval process. For more information : http://www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/guidelines/en/index1.html

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