Regulatory affairs and Pharmacovigilance

Analyzing and recommending the optimal procedure (most favorable from fast track existing ones if applied) for obtaining Marketing Authorization in Kosovo, in compliance with local legislation

Preparation and translation of relevant required documents for the Marketing Authorization procedure as:

Translation of PIL, SmPC, labeling and other professional texts

Translation, formation and designing of brochures and professional leaflets

Formatting and revision of texts by standard KMA legislation and guidelines

Preparation of dossiers for registration of medicinal products under current laws and administrative guidelines and the relevant documentation and modules depending on the application procedures for marketing authorization

Preparation of dossiers for variations of medicinal products under current laws and relevant administrative instructions depending on the documentation types of variations

Analyzing and recommending the optimal procedure (most favorable from fast track existing ones if applied) for obtaining Marketing Authorization in Kosovo, in compliance with local legislation

Preparation and translation of relevant required documents for the Marketing Authorization procedure as:

Translation of PIL, SmPC, labeling and other professional texts

Translation, formation and designing of brochures and professional leaflets

Formatting and revision of texts by standard KMA legislation and guidelines

Preparation of dossiers for registration of medicinal products under current laws and administrative guidelines and the relevant documentation and modules depending on the application procedures for marketing authorization

Preparation of dossiers for variations of medicinal products under current laws and relevant administrative instructions depending on the documentation types of variations

Preparation of dossiers for renewal (re-registration) of medicinal products under current laws and administrative guidelines depending on the relevant documentation and application procedures for renewal

Completion of application forms for registration of medicinal products for the first time based on the Company dossier and depending on the application procedures for marketing authorization under the current law and administrative guidelines

Completion of application forms for variation (Type I and Type II) of medicinal products based on company files depending on the variations type under current law and administrative guidelines

Completion of application forms for renewal (re-registration) of medicinal products based on the company files depending on the application procedures for renewal under current law and administrative guidelines

Monitoring of the registration process, variations or renewals of submission until the conclusion of the procedure (obtaining evidence/approval)

Application for submission of PSUR and Risk Management and reporting of Adverse Drug Reactions and/or side effects of medicinal products registered in the territory of the Republic of Kosovo through CIOMS forms

Monitoring the activities of pharmacovigilance procedures to KMA representation in official meetings with KMA officers

Representation in official meetings with KMA officials

Preparation of application for submission of samples and standards for medical products and procedures for marketing authorization for KMA official national laboratory, under current law and administrative guidelines, importation and clearance of samples and standards of medical products

Importation and clearance of samples of medicinal products and standards

Professional consultation and legal explanations (applies to all laws, and administrative guidelines of KMA, MoH, Import, freight forwarders, health insurance and customs procedures)

Application for approval of promotional materials for OTC products at KMA, under current law and administrative guidelines

Application for approval of promotional materials for RX products at KMA, under current law and administrative guidelines,

Preparation of applications, letters and complaints to the Independent Appeals Board at KMA

Request for withdrawal of a marketing authorization (termination of registration)

Other services as per customer request.