Regulations

22 texts found

• Ligne directrice Guideline for the preparation and submission of registration, modification and renewal applications for pharmaceutical products for human use in Algeria Full text
• Ligne directrice LD-DVIV04V01 Guideline on regulatory inspections Full text
• Ligne directrice Guideline on regulatory reliance and recognition practices for Good Manufacturing Practice inspections Full text
• Ligne directrice Guideline on the modification of pharmaceutical product registration decisions Full text
• Ligne directrice Guideline on regulatory reliance and recognition in the context of registration and modification of registration decisions Full text
• Ligne directrice Guideline on regulatory reliance practices in pharmacovigilance Full text
• Ligne directrice Guideline setting the procedures for relying on regulatory reliance and recognition for laboratory testing of pharmaceutical products for human use Full text
• Ligne directrice Guideline on defining the roles and responsibilities of the entities involved in the pharmaceutical product registration procedure within the ANPP Full text
• Ligne directrice Guideline on the refusal, temporary withdrawal and permanent withdrawal of the registration decision Full text
• Ligne directrice Guideline on communication Full text
• Ligne directrice Guide to Good Distribution and Storage Practices for pharmaceutical products and medical devices for human use Full text
• Ligne directrice LD-DVIV04V01 Guideline on regulatory inspections (LD-DVIV04V01) Full text
• Ligne directrice Rules for drafting product information (SmPC, package leaflet and packaging) for medicines for human use Full text
• Ligne directrice Guideline on the prerequisites for renewing the registration decision Full text
• Ligne directrice Guideline on the requirements for bioequivalence and therapeutic equivalence studies Full text