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Uruguay Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

Safeguarding Public Health Through Comprehensive Regulation

MoH: Ministry of Public Health of Uruguay (MPH)

MoH Website: https://www.gub.uy/ministerio-salud-publica/

Regulatory Authority: The National Drug Board (JND)

Regulatory Authority website: http://www.infodrogas.gub.uy/

Local Authorised Representative: Yes

License Validity: 5 years

Registration Fees: USD 1000 approx.

Type of Dossier:  CTD

Timeline for Market Authorisation:

  • In Uruguay, new medications with established active ingredients may also be approved after 4 months of evaluation.
  • Fast track: 10 to 45 days (if approved)
  • Typical timeline: 15 to 18 months
  • Current medications and presentation: 4 months

Regulations:

  • Law 9,202 (MSP Organic Law),
  • Law 15,443 (Drugs Law), Decree 521/984, Decree 324/999 and Decree 12/007 (Drugs),
  • Decree 3/008 (Medical Devices)
  • Decree 38/015 (Biologicals). 

Registration Procedure for pharmaceutical products

  • All products must be registered with the Ministry of Public Health of Uruguay (MPH) which is done by manufacturers, representatives, distributors and/or importers of the products.
  • For registration of pharmaceuticals, companies must provide the following documents:
  1. Evidence of the registration of the company and the authorization of its premises.
  2. A copy of the documentation attached to the product at its commercialization (brochures, instructions, guarantees, etc.).
  3. Quality certificate granted by an authorized body or Certificate of sales authorization awarded by the accredited institution in the country of origin. If the product does not have these certifications, it can be replaced by an affidavit of the company that registers the product ensuring its quality and safety of it.
  4. Technical documentation specific to the product type must be registered.
  5. Affidavit, certifying that the equipment is new or used. In the case of used equipment, it must be accompanied by the corresponding recycling process, carried out by a trained, qualified and competent company.
  6. The Technical Director and the person in control of the company must sign registration applications. Using the company’s documentation as a guide, officials will decide whether samples or technical inspections are required to finish the investigation. If so, they will notify the relevant company. If an analysis is conducted, an official copy will be issued with details of the examinations made and the results obtained.
  • In general, the following documents are needed for registering products:
  1. Quality Certifications for the production part
  2. Quality Certifications for the product
  3. Certificate of Free Sale from the country of origin of the product
  4. Technical report of the product
  5. Affidavit of maintenance of the equipment during the product life
  6. For used equipment: data about the recycling company and the recycling protocol.
  • In emergency situations, supplier organizations may import reagents, diagnostic reagents, medical equipment and/or therapeutic devices not yet registered, upon request of a competent professional in the matter and approved by the MPH.
  • The application for registration must be made within 30 days.
  • Until the device registration is granted, the signing professional is jointly and severally responsible for any faults.

Drugs Registration

  • The manufacturer or importer of a drug must inform and provide the MSP with the following information to register it:
  1. Proposed name for the drug;
  2. qualitative and quantitative formula;
  3. Active or inactive raw materials monograph.
  4. pharmaceutical form
  5. methodological analytics of the finished product;
  6. description of characteristic of the pharmaceutical form;
  7. qualitative analysis of active raw materials in the finished product;
  8. quantitative analysis
  9. hygienic control of the non-sterile finished product;
  10. sterility control of pyrogenics and safety, as applicable;
  11. stability study of active raw material/s
  12. updated pharmacological basis of the foreseen therapeutic effect of active raw material/s. To demonstrate interchangeability and bio-comparability, further documents may need to be submitted; this will depend on the presence of raw ingredients in other registered or pending medications, as well as whether they have received FDA or EMA approval.
  13. draft prospectus;
  14. labeling design.
  • The time period needed for approval varies depending on the type of proceedings:
  • Standard: around 12–18 months.
  • expedited/accelerated: 30 days

Biologicals:

  1. GMP of the active ingredient’s manufacturer;
  2. evidence of marketing in other countries, in the case of imported products;
  • information on active ingredient/s;
  1. information on the pharmaceutical product;
  2. preclinical information: pharmacodynamics studies, pharmacokinetic studies, toxicity;
  3. clinic information: phase I, II, III and IV studies (if applicable), immunogenicity studies;
  • pharmacovigilance and risks management plan.
  • Approval time for biologicals is approx. 12-18 months.

Biotechnological Similar Drugs:

  1. GMP of the active ingredient’s manufacturer;
  2. evidence of marketing in other countries, in the case of imported products;
  3. information on active ingredient/s;
  4. information on the pharmaceutical product;
  5. quality comparability protocol;
  6. preclinical comparability protocol;
  7. clinical comparability protocol: pharmacokinetic and pharmacodynamics studies, including confirmatory clinical trials to demonstrate the similarity of efficacy between the biosimilar and the reference biologic;
  8. efficacy studies;
  9. security studies;
  10. immunogenicity studies.
  • Approval time for biologicals takes approx. 12-18 months.