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Registration of Medicines by Liaison Offices

posted 2 years ago

Some activities of the liaison offices operating in the pharmaceutical sector are impacted by the new regulation, especially the registration of medicines. Indeed, the registration procedure for medicines consists of a marketing authorization that aims to prevent a pharmaceutical product from being marketed in a country before an authorization is granted by the Minister of Health after the opinion of the national nomenclature commission. Henceforth, the registration of medicines is a regulated activity that appears in the nomenclature of economic activities subject to registration in the trade register under the activity code N° 602121. Indeed, this code allows the exploitation of decisions to register pharmaceutical products, to ensure all operations related to registration, pharmacovigilance, release and monitoring of batches of pharmaceutical products and if necessary, their withdrawal. As a result, the Director and the Liaison Office could be held liable for any violation of the relevant provisions.

In addition, some activities of the pharmaceutical industry are considered in the sense of Article 50 of the Supplementary Budget Law for 2020 as a strategic activity subject to the rule of national ownership resident 51-49%. Therefore, it is essential for liaison offices to take preventive measures to mitigate the risk of liability. 

Do liaison offices have the right to register medicines? 

No, liaison Offices can no longer register medicines. This is because drug registration is a regulated activity.

Besides that, the exercise of commercial activities by the liaison office in the name and on behalf of the foreign commercial company is strictly prohibited by the law under Article 9 of the Order of November 9,2015 defining the conditions and modalities of opening and operating non-commercial liaison offices. In other words, liaison offices are representative structures and cannot carry out commercial or economic activities.

Adding to that, the violation of this provision leads to the withdrawal of the approval, without prejudice to the sanctions provided for by the law. Therefore, the registration of medicines by liaison offices is now strictly prohibited and could result in liability. 

By what means could a foreign company proceed to the registration of medicines? 

Liaison offices could register medicines in two ways. On the one hand, the foreign company could choose to subcontract the registration of medicines without violating the provisions of the law. On the other hand, there could be a risk of liability associated with subcontracting. On the other hand, the registration of medicines could be done through the creation of a company under Algerian law. Nevertheless, some activities of the pharmaceutical industry are strategic activities subject to the 51-49% resident national shareholding rule. Indeed, the pharmaceutical es tablishment of exploitation of the decisions of registration of pharmaceutical products is an activity linked to the pharmaceutical service. Therefore, the registration of medicines by foreign companies is subject to the 51/49 rule for strategic activities (except for activities that are not subject to the 51/49 rule).

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