The Moroccan Agency for Medicines and Health Products has recently granted marketing licenses for three concentrations of a medication containing the active ingredient ‘methylphenidate’, intended for the treatment of children and adults diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). This significant development marks Morocco's transition from a phase of exceptional importation of ADHD medications to a regular supply of these drugs in pharmacies and healthcare institutions, pending the completion of the public pricing determination process.
This announcement comes after inquiries made by the media, following a statement from the Moroccan Observatory for Inclusive Education, which expressed the national committee's regret over the ongoing difficulties in accessing the medications ‘Ritalin’ and ‘Concerta’, one year after pledging to expedite the legal process for these drugs.
In response, the Moroccan Agency clarified that the situation concerning medications containing methylphenidate in Morocco over recent years was not due to delays in the review of applications by regulatory authorities. Instead, it stemmed primarily from the unavailability of these medications in the national market, resulting from a lack of marketing and previous pharmaceutical companies' failure to submit registration requests necessary for legal licensing.
The agency attributed this issue to the unique nature of this substance, classified under strictly controlled materials, which necessitates precise regulatory and technical conditions regarding manufacturing, importation, distribution, and monitoring.
Since its establishment, the agency has prioritized this matter, coordinating with relevant pharmaceutical manufacturing companies to accelerate the registration of these medications. It mobilized various specialized departments to ensure rapid processing of applications while adhering to the scientific and regulatory requirements stipulated by national legislation.
New Licenses Granted
Recent data provided to the media highlights that this file has seen significant progress, thanks to the agency's efforts in collaboration with various stakeholders. The evaluation phase for registration applications has been completed in accordance with the expedited procedure established for this matter, meeting all scientific, technical, and regulatory requirements.
This process has resulted in the granting of marketing licenses for three concentrations of the medication® CONCERTA, which contains methylphenidate. These include: ‘CONCERTA® 18 mg’, which is currently in the pricing determination process; ‘CONCERTA® 36 mg’, which has completed the pricing process and is awaiting publication in the official gazette; and ‘CONCERTA® 54 mg’, which has also completed the pricing determination and is pending official publication.
It is important to note that obtaining marketing authorization, while significant, does not represent the final step before these medications become available in pharmacies. The national legal framework mandates the completion of the public pricing determination process prior to marketing, as this is a necessary regulatory step aimed at facilitating access to the medication within the national market.
Exceptional Importation Measures
While awaiting the finalization of all necessary regulatory procedures for marketing the medications containing methylphenidate, the agency indicated that it would continue to implement necessary measures to ensure uninterrupted treatment for patients. This includes granting exceptional import licenses in accordance with applicable legal provisions to prevent any disruption in treatment for cases that require it.
These licenses are regulated through the exceptional import procedure outlined in Article 7 of Law No. 17-04, which serves as the code for medicines and pharmacy. This provision allows the Moroccan Agency for Medicines and Health Products to authorize the importation of unmarketed medications in Morocco when therapeutic necessity dictates, provided that medical justifications are presented and legal and regulatory conditions are met.
The agency stated that it reviews requests on an individual and urgent basis, granting import licenses to patients or their guardians, or through pharmaceutical manufacturing companies that facilitate the import process, thereby ensuring timely access to treatment.
Additionally, the agency has adopted this mechanism since the outset of managing this file to avoid any interruptions in treatment until the regulatory processes related to national marketing are completed.
As reported by hespress.com.
