Mozambique National Medicines Control Authority (NMCA)
Yes
Pharmaceuticals and Medical Devices
6-12 months
$1,000 to $2,000
5 Years
In Mozambique, the registration of medicines is governed by Law 4/98, enacted on 14th January, which establishes the legal framework for pharmaceutical practices. The registration of medicines is mandatory under this legal framework, and the specific regulations for registration are outlined in the Registration Regulation passed by Decree 22/99 on 4th May.
This involves a simplified process for notifying medicines that already exist in the market and are distributed by licensed operators.
The registration is valid for 3 years, without the option for renewal or exclusivity.
This is the normal registration process required for introducing medicines into the country.
The registration is valid for five years from the date of concession and may be renewed.
Involves the application for registration by acknowledging a registration granted in a country of reference.
Requires the submission of all technical documentation necessary for registration when the Simplified Registration is not possible.
The application for registration can only be submitted by a registered company with a registered office in Mozambique.
These parts are common to both modalities of definite registration (Simplified and Complete).
Part 1-A includes a summary of the registration process.
Part 1-B outlines the characteristics of the medicines under consideration for registration.
The process of registration involves compliance with the outlined legal framework, submission of the required documentation, and adherence to specific modalities based on whether it is an extraordinary or definite registration. This ensures that medicines meet the necessary standards and are authorized for introduction and sale within Mozambique.
Indicate whether the registration process is complete or simplified.
Provide the suggested name for the medicine under consideration.
Specify the amounts and quality of both active and excipient substances in the medicine.
Outline the pharmaceutical-therapeutic rankings associated with the medicine.
Describe the specific pharmaceutical form and dosage of the medicine.
Provide details on how the medicine is presented.
Indicate the period of validity and the recommended storage conditions for the medicine.
Specify any exemption ranking associated with the medicine.
Provide the name and address of the entity applying for the medicine registration.
Identify the manufacturer responsible for producing the finished medicine product.
Provide a comprehensive summary of the key characteristics of the medicine, including:
Include the following information on the medicine label:
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.