Application for Registration of Medicines (Western Medicines)

First Application


How to Apply

Time of application: N/A

Application procedures and documents required:

  1. A duly completed  “Application Form for Registration of Medicine”;
  2. Production licence and registration certificate authenticated by the authority of issue or the Notary Office of the Macao SAR Government, or by a Chinese consulate or Portuguese consulate in the country of issue;
  3. Three samples of the medicine for quality check;
  4. In addition to the above items, the following documents should be submitted to the Health Bureau:
    1. A brief description of drug properties which cover the following items:
      1. Name and content of active ingredients;
      2. Indications;
      3. Contraindications;
      4. Adverse reactions (frequency and severity);
      5. Precautions;
      6. Usage during pregnancy and lactation;
      7. Drug interaction;
      8. Dosage and administration;
      9. Overdose symptoms, emergency treatment and antidote (if available);
      10. Influence on driving and machinery operation;
      11. Incompatibility;
      12. Stability after opening the container;
      13. Storage conditions.
    2. Chemical, pharmaceutical and biological documents (in accordance with the provisions in Decree-Law no.59/90/M, Annex III, Part II)
      1. Master formula of the medicine;
      2. A brief description of the container: nature of container, material composition and the way of opening and closing;
      3. Production process and method of production;
      4. Quality control tests for raw materials, semi-finished products and finished products:
      5. Document submitted should detail the method of assay, specifications, as well as the test results of a specific batch. If necessary, the report should also include a physical, chemical and microbiological / biological testing.
      6. Stability testing:
      7. Includes a stability test for the climate of Macao (climatic zone IV). In addition, the conclusion should include a shelf-life inference – recommended to be performed in accordance with the WHO guidelines on stability testing of pharmaceutical products;
      8. For first-time medicine registration, shelf-life inference can be made based on accelerated stability test; after approval of registration, real-time study is required for validation purpose; (If the product has been registered in other countries, the results of accelerated stability test performed in those countries can also be accepted in the first application of medicine registration in Macao);
      9. If the product requires diluting or mixing before administration (e.g. powder for injection or oral suspension) or is a sterile preparation (e.g. eye drops), a stability test should be performed, after mixing or after the container of sterile preparation is unsealed, in order to determine the shelf life and storage conditions;
      10. Indicate the material property and specifications of the container, as well as the interactions between the container and the product;
      11. Other information.
    3. Toxicological and pharmacological documents (in accordance with the provisions in Decree-Law no.59/90/M, Annex III, Part III)
      1. Toxicity for single administration;
      2. Toxicity for repeated administration;
      3. Research on reproduction;
      4. Mutagenic potential;
      5. Carcinogenic / oncogenic potential;
      6. Pharmacodynamic data;
      7. Pharmacokinetic data;
      8. Local tolerance (if applicable);
      9. Other information.
    4. Clinical documents (in accordance with the provisions in Decree-Law no.59/90/M, Annex III, Part IV)
      1. Information on human pharmacology;
      2. Methods and conclusions of clinical trials;
      3. Other information.
    5. Particular information (in accordance with the provisions of Decree-Law no. 59/90/M, articles 19-20 and Annex III, Part V);
    6. Packaging;
    7. Labelling;
    8. Package insert.

Location of Application and Service Hours

Location of application: Department of Pharmaceutical Affairs, Health Bureau

Address: Avenida Sidónio Pais, n.º 51, Edif. “China Plaza”, 1.º andar, Macau (Receipt and Dispatch Unit)

Service hours:

Mondays to Thursdays: 09:00-13:00; 14:30-17:45

Fridays: 09:00-13:00; 14:30-17:30

Closed on Saturdays, Sundays and public holidays


Fees

MOP1,000【Note】

Notes:

  1. Subject to an additional 10% stamp duty;
  2. According to paragraph 2 of article 9 of Decree-Law no. 59/90/M dated 19th September, “No refund will be made if the initial registration is rejected or if the renewal is not approved after review.”

Application Processing Time

The application file will be handed to the Medicine Registration Technical Committee for resolution within 5 months upon receipt of all required documents.


 Remarks/Notes to Application

  1. If the product does not contain any new drug, does not contain a new mixed preparation which has never been clinically tried consisting of two or more known active ingredients, or if the product complies with any of the conditions provided in paragraph 3 of article 10 of Decree-Law no.59/90/M, the part of other clinical reports, reference books or pharmacopeia in which information on the clinical trials of relevant active ingredients were published can be submitted.
  2. The scientific or technical documents can be presented in either of the three languages, i.e. Chinese, Portuguese or English.
  3. These application procedures are provided for reference only; the provisions in Decree-Law no. 59/90/M dated 19th September shall prevail. For queries, please consult the Division of Pharmacovigilance and Pharmacoeconomics under the Department of Pharmaceutical Affairs of the Health Bureau.

Application Status Enquiry and Result Collection

Method of result collection: In person


Content provider: Health Bureau (SS)

Last modified: 2018-03-21 12:47

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All information on this site is based on the official language of the Macao Special Administrative Region. The English version is the translation from the Chinese originals and is provided for reference only. If you find that some of the contents do not have an English version, please refer to the Traditional Chinese or Portuguese versions.