Understanding Registration in North Africa
A Growing Market in Maghreb
With more than 43 million sheep and 5 million cattle, it is more important than ever, as a pharmaceutical solutions firm, to understand the regulatory procedures for veterinary medicinal products in Maghreb region of Northern Africa. Dr. Rachid Bouguedor, Director of Veterinarian Services in Algeria, in a research report, explains that the livestock plays a critical role in the North of Africa, and reminds pharmaceutical manufacturers that each country has its own distinct regulatory procedures.
A Developing Need for Regulatory Practices
In the Maghreb region, consisting of Morocco, Algeria, and Tunisia, the growing livestock market called for a need for rapid legislation. Over the past few years, North Africa successfully developed a highly regulated market despite the fast growth of the livestock sector and greater use of medical products. Nevertheless, it is not safe to assume that these procedures will all be the same; Pharmaceuticals must understand and comply with the distinct variances in legislation.
Laying the Foundation: Understand the Similarities
Before addressing the differences, it is important to look at the similarities. The process begins with some administrative aspects. In Maghreb the minister responsible for the central veterinary pharmacy department must approve each pharmaceutical specialty. In the application, information about the manufacturer, licenses, and administrative methods and routes must be included. The technical aspects are critical as well. The director is interested in the methods and conditions under which the medical product is manufactured. This is the section of the application where you detail the control processes and all clinical studies with toxicological reports.
The Differences and Significance
The major difference between these three countries is the actual ministry responsible for signing the application and the pricing policies. For Morocco, pharmaceuticals are required to work with the ministries of public health and agriculture and must agree on a fixed price for the products. However, in Algeria and in Tunisia, pharmaceuticals must register with the Ministry of Agriculture and the Ministry of Public Health, respectively. Like Morocco, Tunisia requires the prices of the products to be fixed. In Algeria however, the prices can be set completely free. Having this background knowledge can completely change the marketing strategies for a particular company, so it is important to understand these differences to serve those communities who need it the most.
At the end of his article, Dr. Bouguedor calls for an implementation of good manufacturing practices and good distribution practices. These are not just to be followed by a specific company, but all stakeholders in that sector. If change is to be made it will require a community effort. At Mercator we are proactive in these good manufacturing practices and we hope that you will join us in this endeavor.