| COUNTRY |
JURISDICTION |
SUBJECT |
INSTRUMENT |
LANGUAGE |
FILE
NAME |
| SICA |
Multilateral |
Pharmaceuticals |
Central American Technical Regulation: Labeling of Pharmaceutical Products for Human Use |
Spanish |
RTCAphLab.pdf
 |
| Argentina |
Federal |
Advertising |
Disposition - General & Specific Norms for Publicity or Advertising Directed to the Public Intended to Promote Over-the-Counter Medicinal Specialties, Foods, Cosmetics, Personal Hygiene Products & Perfumes, Cleaning Products, Dietary Supplements, In Vitro Diagnostics & Medical Technologies |
Spanish |
DispANMAT_4980-2005.pdf
|
| Argentina |
Federal |
Advertising |
MSAL Resolution 20/2005 - Promotion of Over-the-Counter Products |
Spanish |
ARGres20-2005otc.pdf
|
| Belize |
National |
Food; Pharmaceuticals |
Food & Drug Act |
English |
cap291.pdf
|
| Bolivia |
National |
Pharmaceuticals |
Medicines Law |
Spanish |
BOLmedsLaw.pdf
|
| Bolivia |
National |
Pharmaceuticals |
Implementing Regulation for the Medicines Law |
Spanish |
BOLmedReg.pdf
|
| Bolivia |
National |
Pharmaceuticals |
Regulation of the National Pharmacological Commission |
Spanish |
BOLpharmacoVigReg.pdf
|
| Bolivia |
National |
Pharmaceuticals |
Ethical Norms for the Promotion of Medicines |
Spanish |
BOLethNormMeds.pdf
|
| Brazil |
National |
Pharmaceuticals |
Law Defining Regulatory Norms for the Pharmaceutical Sector, Creating the Regulatory Chamber for the Medicines Market |
Portuguese |
BZphLaw.pdf
|
| Brazil |
National |
Pharmaceuticals |
Amendment to Law 6.360 Regarding Bioequivalence Test Data for Imported Generic Medicines |
Portuguese |
BZbioequivLaw.pdf
|
| Brazil |
National |
Pharmaceuticals |
Law on the Free Distribution of Medicines to HIV Carriers & AIDS Patients |
Portuguese |
BZaidsMedsLaw.pdf
|
| Brazil |
National |
Pharmaceuticals, Cosmetics & Cleaning Products |
Law 6360/76 on Sanitary Supervision of Medicines, as amended
[Annotated version] |
English |
BZlaw6360-76_eng.pdf
|
| Brazil |
National |
Pharmaceuticals, Cosmetics & Cleaning
Products |
Law 6360/76 on the Sanitary Supervision of Medicines |
Portuguese |
BZlaw6360-76_port.pdf
|
| Brazil |
Espirito Santo |
Waste - Expired Medicines |
Law on Procedures Relating to the Destination to be Given to Medicines Whose Validity Has Expired |
Portuguese |
ESexpMedsLaw.pdf
|
| Brazil |
Mato
Grosso do Sul |
Waste
- Packaging |
Law
Establishing Norms for the Final Destination of Bottles and Other Plastic
Packaging |
Portuguese |
BZ-MS-03.pdf
|
| Brazil |
Paraíba |
Public Health |
Decree Implementing Law 7.069 Instituting the State System of Sanitary Vigilance |
Portuguese |
PBsanVigiDec.pdf
|
| Brazil |
Paraná |
Waste
- Expired Medicines |
Law
on the Responsibility of the Pharmaceutical Industry & Medicine Distribution
Firms to Provide Adequate Disposal of Expired Medicines |
Portuguese |
PRexpiredMedsLaw.pdf
|
| Brazil |
Pernambuco |
Waste
- Expired Medicines |
Law
on the Substitution & Disposal of Medicines Whose Stated Periods of Validity Expire While in
the Control of Pharmacies |
Portuguese |
PEexpiredMedsLaw.pdf
|
| Brazil |
Rio de Janeiro |
Waste - Packaging |
Law 3.369 to Establish Norms for the Final Disposal of Plastic
Bottles |
Portuguese |
BZ-RJ02.pdf
|
| Brazil |
Rio
de Janeiro |
Waste
- Packaging |
Decree
Implementing Law to Establish Norms for the Final Disposal of Plastic Bottles |
Portuguese |
BZ-RJ-02.1.pdf
|
| Brazil |
Juiz
de Fora, MG |
Waste
- Packaging |
Law
Obliging the Take-Back of All Plastic Material Mentioned in This Law Utilized
in the Municipality of Juiz de Fora |
Portuguese |
BZ-MUN01.pdf
|
| Brazil |
Santo
André, SP |
Waste
- Packaging, Tires |
Law
on the Final Disposal & Reuse, Including Through Economic Solidarity
Processes, of Packaging, Plastic Bottles & Tires |
Portuguese |
BZ-MUN-06.pdf
|
| Brazil |
São
Paulo, SP |
Waste
- Packaging, Tires |
Law
Regarding the Collection, Final Destination & Reutilization of Packaging,
Plastic Bottles & Tires |
Portuguese |
BZ-MUN-04.1.pdf
|
| Chile |
National |
Pharmaceuticals |
Supreme Decree 1876/95 - Regulation of the National System
of Control of Pharmaceutical Products (as amended in 2005) |
Spanish |
CHLds1876.pdf
|
| Colombia |
National |
Dietary Supplements |
General Regulation on Dietary Supplements |
Spanish |
COLdietSupReg.pdf
|
| Colombia |
National |
Pharmaceuticals, Cosmetics, Cleaning Products |
Decree on the Elaboration, Packaging, Storage, Transport & Retailing of Medicines, Cosmetics, Natural Pharmaceutical Preparations, Cleaning Products & Other Household Products (as amended) |
Spanish |
COLphCosDec.pdf
|
| Colombia |
National |
Pharmaceuticals, Cosmetics |
Resolution - Standards Regarding Labels, Packaging, the Use of Stickers and Authorizations of Depletion of Packaging |
Spanish |
COLphCosLabPkg.pdf
|
| Colombia |
National |
Pharmaceuticals |
Resolution - Criteria for the Classification of OTC Medicines |
Spanish |
COLotcPHres.pdf
|
| Colombia |
National |
Pharmaceuticals |
Resolution - Advertising of OTC Medicines & Phytotherapeutic Products |
Spanish |
COLotcAdv.pdf
|
| Colombia |
National |
Pharmaceuticals |
Regulation on Good Manufacturing Practices (GMP) for Pharmaceuticals |
Spanish |
COLphGMP.pdf
|
| Colombia |
National |
Pharmaceuticals |
Regulation on International Donations of Medicines |
Spanish |
COLdonations.pdf
|
| Costa Rica |
National |
Pharmaceuticals |
Regulation on the Registration, Control, Importation & Advertising of Medicines (as amended) (annotated) |
Spanish |
COSmedCntl.pdf
|
| Guyana |
National |
Food, Pharmaceuticals |
Food & Drugs Acts |
English |
GUYcap3403.pdf
|
| Guyana |
National |
Pharmaceuticals |
Antibiotics Act |
English |
GUYcap3402.pdf
|
| Mexico |
Federal |
Pharmaceuticals |
NOM on Good Manufacturing Practices for Pharmaceutical Industry Establishments Dedicated to the Manufacture of Medicines |
Spanish |
MXphGMPnom.pdf
|
| Mexico |
Federal |
Pharmaceuticals |
NOM on Medicine Labeling |
Spanish |
MXphLabNOM.pdf
|
| Mexico |
Federal |
Pharmaceuticals |
NOM on the Installation & Operation of Pharmacovigilance |
Spanish |
MXphVigNOM.pdf
|
| Nicaragua |
National |
Pharmaceuticals |
Law of Medicines & Pharmacies |
Spanish |
NICphLaw.pdf
|
| Nicaragua |
National |
Pharmaceuticals |
Revision of the Implementing Regulation for the Law of Medicines & Pharmacies (2000) |
Spanish |
NICmedDec2000.pdf
|
| Panama |
National |
Pharmaceuticals |
Law 1 of 2001 on Medicines & Other Products for Human
Health |
Spanish |
PAAley2001_001.pdf
|
| Panama |
National |
Pharmaceuticals |
Implementing Regulation of Law 1 of 2001 on Medicines & Other Products for Human Health |
Spanish |
PAAmedsDec.pdf
|
| Paraguay |
National |
Sanitary Control |
Law 119/97 on Health Products |
Spanish |
PARhlthProdLaw.pdf
|
| Peru |
National |
Pharmaceuticals |
Decree on Qualiy Control & the Provision of Information on Medicines |
Spanish |
PERmedsDec.pdf
|
| Peru |
National |
Pharmaceuticals |
Regulation on Clinical Trials |
Spanish |
DS017-2006SA.pdf
|
| Peru |
National |
Pharmaceuticals |
Amendment of the Regulation on Clinical Trials |
Spanish |
DS006-2007EP.pdf
|
| Peru |
National |
Pharmaceuticals |
Directive on Inspection & Certification of Compliance with Good Manufacturing Practices |
Spanish |
PERphGMP.pdf
|
| Peru |
National |
Pharmaceuticals, Cosmetics, Cleaning Products, Personal Hygiene Products |
Regulation for the Sanitary Registration, Control & Vigilance
of Pharmaceutical & Related Products (annotated) |
Spanish |
PERsanCntlReg.pdf
|
| Peru |
National |
Public Health |
General Health Law |
Spanish |
PERgenHealth.pdf
|
| Uruguay |
National |
Pharmaceuticals |
Decree-Law on on the Importation, Representation, Production,
Elaboration & Sale of Pharmaceuticals |
Spanish |
URUpharmaDecree.pdf
|
| Uruguay |
National |
Pharmaceuticals |
Decree on Bioequivalency Studies |
Spanish |
12173.pdf
|
| Venezuela |
National |
Pharmaceuticals |
Medicines Law |
Spanish |
VENLeyMeds.pdf
|
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