BOLIVIAN REQUIREMENTS FOR REGISTRATION OF MEDICINAL PRODUCTS

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MANUFACTURING
LABORATORY

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Part I. Legal Documents and Certifications.

* Drugs Registration and Quality Control Request form (SNS-DINAMED-005), with qualitative and quantitative formula, which has to be fill up and sign by the accredited pharmacist of our company.

* Photocopy of Secretarial Resolution of the company, it is the legal document that authorises our company to import and trade with drugs in the country.

* Photocopy of certification of annual payment (reinscription) at the Ministry of Health of the company

* Photocopy of previous sanitary register (only for reinscription or change)

* Certificate of quality control given by the Official Quality Control Laboratory (known as INLASA) only in case of reinscription. This certificate is given by the national authorities after they have analysed a sample taken in any drugstore in Bolivia (only for reinscription )

* Certificate of quality control given by the manufacturer, referring Pharmacopoeia

* Authenticate by a Bolivian consulate of the original certificate of pharmaceutical product subject to international commerce, given by your national authorities, in which it mentions that the Manufacturer Laboratory accomplish the Good Manufacturing Practices.

* Qualification request form, (SNS-DINAMED-007) referring the most important phamacological information (this form is fill up by our pharmacisit according with the information you provide).

* Pharmacological Information (according with the requirements detailed down below.

* Labels, prospectus and original containers.

Note: The first two columns indicates the requirements that we will provide and the ones you have to send us.

INSTRUCTIVE FOR PRESENTATION OF PHARMACOLOGICAL MONOGRAPH

The pharmacological monograph to be presented, constitutes documentation of a great deal of importance, by which should be taken into account all the points indicated subsequently. 

I.  FIRST PART: general Information.-

-   Brand Name (when exists), International Non-property Name (INN), Manufacturing Laboratory, Pharmaceutical presentation, Strength, Quali-quantitative formula, Chemical Structure, Ways of administration, Therapeutic Action, Mechanism of action, Dose, Indications, Contraindications, Medical problems, Precautions, Side adverse effects, Drug interactions; Pharmacokinetics, Pharmacodinamics

II.  SECOND PART: Pharmacokinetics characteristic.-

-   Mechanism of action, Absorption, Distribution, Biotransformation, Elimination, Excretion bias of the placent barrier, in brest feeding, Biodisponibility

III.  THIRD PART: Information toxicol�gica.-

They will be consigned, as new drugs, the drugs whose presence in the pharmaceutical market is less than five years.

Besides the documentation indicated, for the case of new drugs, should be added the following information:

-   Toxicity sharp, DL in two species 50, Maximum dose tolerated, Minimum dose, Toxicity due to repeatedly dose, Subacute Toxicity, Sub chronic toxicity, Chronic toxicity, Carcinogenicity, Mutagenicity, Pregnancy and reproduction, Study of fertility

Complementary information.-

-   Similarity with other drugs, Experimental pharmacological trials, Pharmacological trials, clinical and pre-clinical, Synergic and antagonic effects

IV.  FOURTH PAST: Label and prospect.-

It should be included the model of the label and prospect of the product for its approval.

V.  FIFTH PART: complementary Information.-

Any information that the interested consider important should be added in this part, indicating the corresponding references. 

Bibliographic reference.- The photocopies of reference included, should be the ones of publications recognized internationally.

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