• National procedures applications
• Mutual Recognition Procedure applications (Portugal acting as Reference Member State or as Concerned Member State)
• Decentralised Procedure applications (Portugal acting as Reference Member State or as Concerned Member State)
• Centralised procedures applications
• Parallel import applications
• Exceptional Use Authorisation (“AUE” applications, batch use “AUE” application, Commercialization of medicinal products without MA granted in Portugal Use application “SAR”)
• Early Access Program (EAP) application

Pharmaffairs is your partner of excellence if you need the approval of a procedure in multiple Member States. Pharmaffairs also provides support in the analysis, submission, monitoring and finalization of the procedure.

Pharmaffairs has experience in specific areas such as:
– Medicinal product gases;
– Homeopathic medicinal products;
– Herbal medicinal products

CTD elaboration and reformat MA dossiers

• Variation Type IA, IA_IN, IB and II;
• Labelling elaboration and analysis (SPC, PIL and Label);
• MA dossier CTD adaptation/restructuration;
• MA renewal;
• MAH transfer.

• Document structure analysis and preparation;
• Document integration in eCTD/NeeS format according to specific and validated (licensed) software;
• Hyperlink creation;
• Project delivered in “ready for submission” format;
• Maintenance and update services of MA dossiers in eCTD/NeeS format.

Pharmaffairs provides the eCTD / NeeS service through a consolidated experience over the years with the implementation and use of state-of-the-art software and accepted in all Member States.

• Promotional and non-promotional material medical and regulatory review and approval;
• Notification of promotional materials support and management;
• Opinion related to promotional activities;
• Notification of promotional activities support and management.

• New product’s strategies;
• Submission strategies;
• Regulatory strategies opinion/assessment;
• Data analysis/evaluation;
• Project management.

Pharmaffairs Pharmacovigilance services are performed according to the GVP and all applicable legislation and guidance, customised to your needs (“end-to-end” solution or specific support to a given sub-area).

• Pharmacovigilance Quality System development, implementation and maintenance;
• EudraVigilance registration;
• Electronic reporting;
• Pharmacovigilance System Master File development and maintenance;
• Article 57 of EU Regulation 726/2004 registration and maintenance activities;
• QPPV services;
• Local contact person for Pharmacovigilance;
• Periodic Safety Reports Updates;
• Urgent Safety Measures management, implementation and ongoing support;
• Pharmacovigilance procedures elaboration;
• Risk Management Plan elaboration, implementation and maintenance;
• RLocal and International medical/scientific Literature search;
• Pharmacovigilance audits;
• Support in Pharmacovigilance inspections;
• Medicinal product safety profile monitoring (including GVP signal detection);
• HealthCare Professional Communication and Educational Materials (including elaboration, review, approval (communication with Health Authority), implementation and effectiveness monitoring);
• Pharmacovigilance training (specific training needs identification, training materials development, knowledge evaluation, training “refresh” and monitoring of training efficacy);
• Medical Inquiries management.

• Complete Readability Test development in “ready to submit” format;
• Bridging reports elaboration in “ready to submit” format.

• ISO 9001 Quality Management System development, implementation and maintenance.

• Price applications;
• Annual price review application;
• Exceptional Price review application;
• Change price application – Notified price regime;
• Reimbursement application.

• Submission of Applications for Certificates of a Pharmaceutical Product (WHO Model) to National Health Authority (INFARMED);
• Legalization of Certificates of a Pharmaceutical Product by embassies/consulates in Portugal.

• Support to Quality Assurance/Technical Direction activities (including acting as GDP QP) Elaboration and implementation of Quality Management Systems;
• GDP Wholesaler activity application (including medicinal products gases);
• Quality audits;
• Support in Quality Assurance inspections.

• Regulatory Compliance project assessment and presentation of action plan;
• Corrective and preventive measures plan implementation (including MA variation elaboration, if applicable);
• Due diligence.

• Clinical Trial application submission to INFARMED, IP;
• Clinical Trial application submission to CEIC (Ethic Committee);
• RNEC platform management;
• Clinical Trial Pharmacovigilance activities.

• Evaluation support to Medical Device Conformity;
• Medical Device registration;
• Medical device classification evaluation support;
• Life-cycle maintenance activities;
• Technical Responsible activities;
• GDP Wholesaler activity application;
• Quality audits;
• Support to Quality inspections;
• Medical devices publicity (including promotional material review and approval and promotional activities assessment and support);
• Medical Device Vigilance;
• Support to health technology evaluation.

• Labelling conformity evaluation of food supplements according to the Portuguese and European Legislation;
• Food supplement notification application;
• Life-cycle maintenance activities;
• Elaboration, submission, management and maintenance National code application;
• Food supplement publicity;
• Food supplements vigilance.

• Cosmetic conformity evaluation support;
• Cosmetic registration;
• Life-cycle maintenance activities;
• Cosmetic publicity;
• Cosmeticvigilance.