Drugs
HEALTH LICENSE/REGISTRATION
Drugs
1 Concept
2 Services
3 Registration – Requirements
4 Health License / Sanitary Registration NOT Requirement Certificate
5 Product classification Certificate
6 Health License Validity
1. Concept
It is any preparation or pharmaceutical form, whose composition formula expressed in units of the international system, is constituted by a substance or mixture of substances, with constant weight, volume and percentages, elaborated in legally established pharmaceutical laboratories, packaged or labeled for be distributed and marketed as effective for the diagnosis, treatment, mitigation and prophylaxis of a disease, physical abnormality or symptom, or the restoration, correction or modification of the balance of the organic functions of humans and animals.
2. Services
- Obtaining the Sanitary Registry / Health Record for Foreign Manufactured Medicines / Drugs.
- Modification of the Sanitary Registry / Health Record for Foreign Manufactured Drugs.
- Re-registration the Sanitary Registry / Health Record for Foreign Manufactured Drugs.
- Health License / Sanitary Registration NOT Requirement Certificate
- Management for destruction of drugs.
- Request for out of stock and labels.
- Obtaining foreign GMP code.
3. Registration
The following documents are required according to the type and level of risk of the drug:
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- Current Certificate of Good Manufacturing Practices – GMP, issued by the competent authority of the manufacturer’s origin country.
- Duly legalized authorization of the owner product to request the sanitary registration / health license, in Spanish. The document must be legalized.
- Batch code interpretation.
- Stability study of the finished product carried out under the humidity and temperature conditions corresponding to climatic zone IV (ICH Guide).
- Finished product Specifications.
- Description of the nature of the primary and secondary packaging and their physical / chemical specifications.
- Quali-quantitative formula
- Certificate of quality control analysis with quality specifications and purity limits of raw materials.
- Analysis procedures for the identification, quantification, and evaluation of the physical, physicochemical, chemical, biological, microbiological, pharmacological characteristics of the finished product.
- IN VITRO equivalence studies (when applicable).
- IN VIVO equivalence studies only required for high health risk products.
- Description of internal quality control procedures during the manufacturing process.
- Original product labels.
- Labels project that will be marketed in Ecuador, which must be written in Spanish.
- A leaflet or insert must be included in all external packaging, which must be in accordance with current pharmacological regulations and international scientific reports.
- Description of the drug manufacturing process, including a process flow chart, which includes the stages, points where material enters, and indicating intermediate steps, critical points, and process controls.
- Current pharmacological and clinical documentation that demonstrates the validity of the therapeutic indications proposed by the manufacturer for the product in process.
- Analytical certificate of finished product.
- Certificate of Pharmaceutical Product (CPP) according to the WHO model or the Certificate of Free Sale (FSC) issued by the competent health authority of the origin country of the product. The document must be legalized.
4. Health License
Service that verifies if the product requires or not requires the sanitary registration / health license for the distribution, commercialization, and import.
5. Product Classification
Process directed to informing the user about the category to which the product belongs, which requires obtaining health registration for subsequent marketing.
6. Health License Validity
The License will be valid for 5 years, counted from the date of its issue and may be renewed for equal periods. (Re-registration).