                                                                                                   Unofficial translation  
from Romanian  Language  
 
Parliament of the Republic of Moldova  
L A W  
Amending and Supplementing Certain Legislative Acts  
No. 24 of 23. 02.2018  
Official Gazette No.84 -93/177 of 16.03.2018  
                                                                               *** 
For the purpose of transposing the provisions of Articles 10, 10a, 10b and 10c of Directive 2001/83 / 
EC of the European Parliament and of the Council of 6 November 2001 on the Community code 
relating to medicinal products for human use, published in the Official Journal of the European 
Union L 311 of 28 November 2001,  
The Parliam ent hereby adopts this organic L aw. 
 
Article I. -  Law No.1456/1993  on P harmaceutical  Activity ( republished in the Official 
Monitor  of the Republic o f Moldova, 2005, No. 59 -61, Article 200), as  subsequent ly amended and 
supplemented, shall be supplement ed as follows:  
1. In Article 1, after the term “unau thorized medicinal product ” the following terms shall be 
introduced:  
“data protection period  - the period during which the holder of the preclinical and 
clinical trials data has the right to prohibit the use of such data;  
marketing protection period  - the period during which a generic medicinal product 
cannot be placed on the market;   
first authorization  - authorization obtained for the first time anywhere in th e world for an 
original medicinal product ;“. 
2. The Law shall be supplemented with Article 115, word ed as follows:  
“Article 115. Data protection and protection of the placing on the market of 
pharmaceuticals  
(1) By way of derogation from the legislation on trade secrecy and access to information 
and without prejudice to  the legislation on  industrial property  protection, holders of 
an original medicinal product for which marketing autho rization is requested shall  
benefit from a 5 -year period of data protection for  preclinical and clinical trials from 
the date of authorization and an additional 2 -year period of  marketing protection for 
the medicinal product concerned.  
(2) The 2 -year period of market protection referred to in paragraph (1) may be extended 
to a maximum of 3 years if, during the da ta protection period for tests and trial s, the 
marketing authorization holder obtains an  authorization for one or more new 
therapeutic indications thereof which, following a scientific evaluation prior to the 
authorization of the medicinal product, are considered to bring signific ant clinical 
benefits in comparison with  existi ng therapies  provided th at significant preclinical 
tests and clinical trials are carried out and presented wi th regard to the new 
indication/ new indications.  (3) During the  data protection period of the original medicine test data, any  other 
manufacturer may r efer to  preclinical and clinical documentation contained in the 
registration file  of the medicinal product for the purpose of submitting an application 
for a marketing authorization of a generic medicinal product, unless  the holder of the 
original medicine  test data provides consent . Upon expiry of the data protect ion 
period for the original medicine  test, reference may be made to the preclinical and 
clinical documentation contained in t he registration file  of the medicinal product 
concerned without the con sent of the holder of the se data. If a registration certificate 
for a generic medic inal product has been obtained o n the territory of the Republic of 
Moldova prior to requesting such authorization from the holder of the original 
medicinal product, the righ ts granted under this Article shall not be invoked with 
respect to the generic medicinal product.  
(4) Only the information that the applicant is required to submit for obtaining the 
registration certificate for the medicinal product and which relates to:  
- pharm aceutical (physico -chemical, biological or microbiological) tests;  
- preclinical (toxicological and pharmacological) tests;   
- clinical studies.  
fall under the provisions  relating to medicine test data.  
 
(5) Presentation of the results of pr eclinical and clinical trials shall  not be mandato ry if 
the applicant proves that the medicinal product  is a generic  product of a reference 
medicinal product  manufactured under the Good Manufacturing Practices (GMP) and 
registered by the European Medicines Agency  (EMA) and the U.S. Food and Drug 
Administration (FDA) for at least 8 years.  
(6) The applicant for the registration certificate  of a generic medicinal product shall  
present appropriate bioavailability studies to demonstrate bioequival ence with the 
reference medicinal product . The different  salts, esters, ethers, isomers, mixtures of 
isomers, complexes or derivatives of an active substance shall be  considered to  be the 
same active substance unless they differ significantly in properties with regard to 
safety and/or efficacy. In  such cases, additional information intended to provide proof  
of the safety and/ or efficacy of the sal ts, esters or derivatives of an  authorized active 
substance  must be supplied by the applicant . The various immediate -release oral 
pharmaceutical forms are  considered to be the same pharmaceutical form. The 
applicant is not required to carry out bioavailability studies if he can demonstrate that 
the generic medicine meets the relevant criteria as defined by the applicable detailed 
guidelines.  The various imm ediate -release oral pharmaceutical forms shall be 
considered to be one and the same pharmaceutical form. Bioavailability studies need 
to be required of the applicant if he can demonstrate that the generic medicinal 
product meets the relevant criteria as de fined in the appropriate detailed guidelines.  
(7) In cases where  the medicinal product does not fall u nder the definition  of a generic 
medicinal product  according to paragra ph (6) or where  bioequivalence can not be 
demonstrated through  bioavailability studies o r in the case of  changes to the active 
substance (s), therapeutic indications, dosage, pharmaceutical form or route of 
administration in relation to the reference m edicinal product, the results  of the  
appropriate  preclinical tests or clinical trial s shall be provided by the applicant for 
the registration certificate of a generic medicinal product . 
(8) Where a biological medicinal product which is similar to a reference medicinal 
product does not meet the conditions in the definition of a generic medicinal produ ct, 
owing to, in particular, differences relating to raw materials or in manufacturing processes of the  similar  biological medicinal product and the reference biological 
medicinal product,  the results of appropriate preclinical tests or clinical trial s relating 
to these conditions must be provided  by the applicant for the registration certificate of 
a generic medicinal product.  The type and quantity of supplementary data to be 
provided must comply with the relevant criteria provided for by the legislation . The 
results of other tests and trials from the  reference medicinal product` s dossier shall 
not be provided.  
(9) The applicant for the registration certificate of a generic medicinal product shall  not 
be required to provide  the results of the preclinical tests and clinical trials if he can 
demonstrate that the medicinal product or the active substances of the medicinal 
product  are in well -established medicinal  use for at least 10 years , with recognized 
efficacy and a an acceptable level of safety  under the condi tions provided for in this 
Law. In this case, the applicant may only refer to  the results of the tests and trials 
provid ed for the first time anywhere in the world within the authorization procedures 
or may replace these data with the appropriate scientifi c documentation.  
(10) In the case of medicinal products containing active substances use d in the 
composition of authoriz ed medicinal products but not hitherto used in combination 
for therapeutic purposes, the results of new pre -clinical tests or new clinical tr ials 
relating to that combination shall be provided, but it shall not be necessary to provide 
scientific references relating to each individual active substance.  
(11) Pursuant to this Article, protection will be granted exclusively to those data 
related to medi cinal products the provision  of which is mandatory in the marketing 
authorization procedure for the medicinal product.  
(12) Exceptions to the provisions on the data protection and the protection of the 
placing on the market of medicinal products  are made in exc eptional situations  in 
accordance with Article 11 paragraph (7) of this Law  or in other cases that might 
endanger the  public health acc ording to Article 28 paragraph (3) of Law No.50/2008 
on the Protection of Inventions.”  
 
Article II. - Law No.1409/1997  on Medicinal Products (Official Monitor of the Republic of 
Moldova, 1998, No. 52 -53, Article 368), as subsequently amended and supplemented, is 
hereby amended and supplemented as follows:  
1. In Article 3, the term “ original medicinal product ( novelty or new chemical 
entity)” shall be replaced by “ reference  (original) medicinal product    ” , worded 
as follows : 
“reference (original) medicinal product  shall mean  a medicinal product  
authorized for the first time anywhere in the w orld based on its own preclinical 
tests and clinical trials;” . 
2. Article 61: 
in paragraph (3), the word “original”  shall be replaced by the words “reference  
(original) ”; 
in paragraph (4), the word “original” shall be replaced by the words “reference  
(origina l)”. 
3. Article 14 shall be supplemented by paragraph (2) as follows:  
“(2) Authorization of a  generic medicinal product shall be  made  separate ly from 
that of the (original) reference medicinal p roduct.”  
  Article III.  – (1) This Law shall enter into force on the day of its publication in the Official 
Monitor of the Republic of Moldova, except for the provisions of Article I paragraph 2, which shall 
apply from 1 January 2020.  
 (2) The Government  shall , within 6 months from t he date of publication of this L aw, align its 
normative acts with this L aw. 
 
 
CHAIRMAN OF THE PARLIAMENT                      Andrian CANDU  
 
No.24. Chisinau, 23 February 2018                             
 
 
 
 
 