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PP and DM acceptance forms
Reception forms for pharmaceutical products and medical devices.
Renewal of registration decision
Draft setting out the prerequisites for renewal of the registration decision.
Checking regulatory compliance
Draft directive on regulatory compliance verification practices in Algeria.
Approval of wholesalers
Consultation on the directive on the authorisation of wholesale distribution establishments.
Control of heat-sensitive products
A reminder of the documentation and control requirements for heat-sensitive pharmaceutical products.
Classification of inspection deviations
Directive on the classification of observations from GMP inspections according to risk level.
Electronic submission of dossiers
Obligation to submit files in merged PDF format for integration into ANPP databases.
Bioequivalence and therapeutic equivalence
Publication of requirements for bioequivalence and therapeutic equivalence studies.
Raw materials regulation certificate 2026
New procedure via the ROAYA platform for raw materials regulation certificates.
Recall and withdrawal of non-compliant products
Guide to procedures for recalling and withdrawing non-compliant medicines and devices.
Assessment of medical devices
Weekly organisation of the processing of medical device approval files.
Recognition of marketing authorisation
Draft directive laying down the procedures for recognising marketing authorisation decisions.
Refusal and withdrawal of registration
Draft setting out the procedures for refusal, temporary or definitive withdrawal of registration decisions.
Preparing and submitting dossiers
Draft directive on the preparation and submission of registration dossiers.
Registration roles and responsibilities
Project defining the roles and responsibilities of the entities involved in the registration procedure.
RCP rules, labelling and leaflets
Draft directive on the drafting of the SPC, labelling and package leaflet for medicinal products for human use.
Publication of the pharmacovigilance guide
The Algerian guide to good pharmacovigilance practice is now available online on the ANPP website.
Directive on regulatory confidence and inspections
Draft guideline on regulatory confidence and pharmaceutical inspection in public consultation.
Advanced Medpharma informs its partners and stakeholders in the pharmaceutical sector
The National Agency for Pharmaceutical Products (ANPP) has published three draft strategic guidelines aimed at strengthening the regulatory framework in Algeria. These documents...
Frequently asked questions
If you have any questions, do not hesitate to contact us or schedule a free consultation with our team of experts.
What services does Advanced MedPharma offer?
We support manufacturers, importers and distributors in the preparation, submission and follow-up of regulatory dossiers for medical devices and pharmaceutical products. We also offer regulatory monitoring, technical translation and strategic consulting services.
In which countries we can offer our services ?
We are based in Algeria and operate throughout the Algerian market and the MENA region, depending on our partners' regulatory requirements.
What is the timeline to complete registration?
Duration varies by product type and regulatory category. Thanks to our experience and relationships with the competent authorities, we optimize each step to significantly reduce approval times.
Do you offer any follow-up?
Absolutely. Our commitment doesn't end with approval: we provide ongoing monitoring to maintain compliance, renewals and management of regulatory updates and post-marketing follow-up in relation to matheriovegilence and pharmacovigilance as a local representative.