LAW OF THE REPUBLIC OF TAJIKISTAN 
ON INTRODUCTION OF AMENDMENTS AN D ADDITIONS TO THE LAW OF 
THE REPUBLIC OF TAJIKISTAN “ON PHARMACEUTICALS AND 
PHARMACEUTICAL ACTIVITIES” 
Article 1 . To introduce following amendm ent and additions to the Law of the 
Republic of Tajikistan as of Aug ust 6, 2001 “On pharmaceuticals and 
pharmaceutical activity” (Bulletin of the Majl isi Oli of the Republic of Tajikistan, No. 
7. Page 499 2001; №12 page 700 2003; №5 page 375 2007; No. 6, page 467 
2008): 
1. To add paragraphs 31, 32, 33 and 34 to th e Article 3 that read as follows: 
"Pharmaceutical substances are pharma ceuticals in the form of active 
biotechnological, biological, mineral  or chemical substances that possess 
pharmacological features used for the pro duction, manufacture of pharmaceuticals 
and determining their therapeutic efficacy. 
Circulation of pharmaceuticals - development, preclinical and clinical researches 
appraisal, state registration, standardization  and quality control, efficiency, safety, 
production, manufacture, sto rage, transportation, import  and export to/from the 
territory of the Republic of Ta jikistan and its dispensing, sale, use, application, 
advertisement and destruction of pharmaceuticals. 
Invented name of the pharmaceutical is the name of a drug determined by its 
manufacturer. 
Certificate of pharmaceutical product and m edical supplies is a document that sets 
the legal status of a particular product as medical or pharmaceutical product and 
allows its use in healthcare.  
2. Article 8: 
- To add the words “ pharmaceuticals and” in the title and af ter the “control” in 
the first part; 
- To add second, third and fourth parts that read as follows:            
“State Control of pharmaceutical activity and pharmaceuticals in the Republic of 
Tajikistan is arranged over the production of drugs within the country and their 
import to the territory of the Republic of Tajikistan. 
State control of circulation of pharmaceuticals includes the control over the clinical 
trials of drugs, quality, efficiency, production, manufacturing, storage, transportation, import/export  to/from the territory of the Republic of Tajikistan, and 
dispensing, sale, use, application,  advertisement and destruction of 
pharmaceuticals. 
State control over the circulation of the pharmaceuticals is arranged via: 
- Verification of compliance with the rules of  laboratory and clinical practices in 
during the preclinical and clinical studi es of drugs used in health and veterinary; 
rules for the organizati on of production, quality control of pharmaceuticals, 
wholesale trade of drugs, manufacturing and dispensing of drugs, storage and 
disposal of pharmaceuticals; - inspections for compliance with the conditions and requirements of issued 
licenses; 
- verifications of quality of drugs; 
- studying and monitoring the effectiveness and safety  of pharmaceuticals; 
- obtaining information on prices and m argins (markups) from state agencies 
and entities handling the circulation of pharmaceuticals; 
- second and third parts shall be  considered as part 5 and 6 respectively. 
 
3.  To replace the word “institutions” with “legal persons and individual 
entrepreneurs” in the second part of the article 10.  
 
4. To complement Part 2 of the Article 12 with th e wording “as well as 
pharmaceutical substances” af ter the word "means.” 
 
5. To replace the words “in pharmacies” with the "legal persons and individual 
entrepreneurs that have a license for pharmaceuti cal activity” in the fourth part 
of the article 14. 
 
6. To add the wording “legal persons and indi vidual entrepreneurs” after the word 
“institutions” in the first part of the article 16. 
 
7. Article 20: 
- to replace the word “pharmacies” with  the wording “pharmacies, including 
individual entrepreneurs” in the third part; 
- to add fourth, fifth, sixth and seventh  paragraphs that read as follows: 
"State registration shall be prohibited, if: 
- Two or more drugs having different compositions are produ ced under the same 
brand name; 
- the same drug is manufactu red by the same manufactu rer under the different 
trade names and submitted for state registration as two or more drugs. 
Registration certificate is given to the r egistered drug for the p eriod of five years 
with indication of dosage forms and quantization (dosage). 
Subsequent confirmation of the registration certificates is arranged prior to the 
expiration of the registration certifi cate by the Author ized agency of the 
Government of the Republ ic of Tajikistan responsible for the state control of 
pharmaceutical activities on the basis of the application of the holder of registration 
certificate. 
Information on pharmaceuticals and medi cal products that have passed state 
registration at the demand  of the natural or legal persons can be confidential if: 
- a drug or its composition is not k nown to persons engaged in the similar 
activities and manufactur er has to keep it secret; 
- secrecy is conditioned by its commercial value; 
- Fourth and fifth parts shall be cons idered as parts eight and nine.  
8. Article 30: 
- to add the words “and individual entr epreneurs” after the wor ds "legal persons" 
in the first part; 
- to add part 3 that reads as follows: 
"Individuals with secondary  or higher professional pharmaceutical education and 
who have a professional certificate in phar maceutical activities may engage in 
pharmaceutical activities (intake, storage, retail sale of pharmaceuticals and medical goods) as individual entrepreneur s after the obtaining  of a certificate of 
state registration as an individual entrepreneur"; 
- Third, fourth and fifth parts shall be  considered as parts four, five and six 
respectively. 
Article 2 . Present Law shall come into force after its official publication.  
President         Emomali Rahmon 
Republic of Tajikistan  
 Dushanbe July 3 2012  # 861