. /.RESTRICTEDWORLD TRADE
ORGANIZATIONIP/C/W/288/Add.3
26 September  2001
(01-4591)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  Spanish
REVIEW OF LEGISLATION
Replies by Nicaragua to the Follow-Up Questions Posed by Switzerland
Addendum
By means of a communication from the Permanent Mission of Nicaragua, dated
21 September 2001, the Secretariat has received th e following replies to the follow-up questions
posed by Switzerland, which were circulated in document IP/C/W/263/Add.1.1
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A. PROTECTION OF UNDISCLOSED INFORMATION
Ad response to question 6:
A. Referring to the issue of unfair commercial use of data submitted by an applicant to the
responsible State agency in the procedure for market authorization of a pharmaceutical or of an
agricultural chemical product, please explain in detail if your legislation explicitly prohibits a
second applicant from relying on, or from referring to the original data of the first applicant,
when applying subsequently for market authorization for his own product.
The information supplied to an administrative  authority to obtain authorization for the
marketing of a pharmaceutical or an agrochemical product may not be disclosed by the authorities
which received it, save where necessary to protect the public.  The foregoing means that the
authorities may not supply the second applicant with the information provided by the first applicant.2
B. Does the responsible State agency require the same amount of data from the secondapplicant as from the first applicant?
In order to obtain approval for the marketing of a pharmaceutical or agrochemical product, it
is necessary to prove that the product is harmless and, in the case of pharmaceutical products, also to
demonstrate the effectiveness of the product.
3
In the case of pharmaceutical products, when authorization is requested for the marketing of a
product containing new substances not recognized in pharmacopoeias and approved lists of
                                                     
1 Nicaragua's replies to the initial questions posed by Switzerland were circulated in
document IP/C/W/288.
2 Decree 6-99, Regulation to Law No. 292, Law on Drugs and Pharmacies, Article 24.3, page 558 of
the Official Journal La Gaceta , No. 24 of 4 February 1999.
3 Articles 21 and 22 of Law No. 292, Law on Drugs and Pharmacies (Official Journal La Gaceta ,
No. 103 of 4 June 1998).IP/C/W/288/Add.3
Page 2
pharmaceutical specialities, the applicant is required to submit toxicological studies4  which serve to
guarantee its safety under normal conditions of use, and in addition to provide data relating to the
planned duration of treatment.  Where the informa tion on effectiveness, safety and adverse reactions
of the active ingredients is recorded in pharmacopoeias and approved lists of pharmaceutical
specialities, submission of the above-mentioned studies is not required.  In all cases, theadministrative authority requires documentation certifying the qualitative and quantitative
composition of the product.
5
In the case of agrochemical products, information must be provided on the active ingredient,
the physical and chemical properties of the product and its effects.  Chemical pesticides must be the
subject of a favourable opinion issued by the sanita ry authorities, who proceed in accordance with the
terms of the previous paragraph, depending on whether or not the product contains a known activeingredient.
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4 Article 20 of Law No. 292, published in the Official Journal La Gaceta , No. 103 of 4 June 1998.
5 Article 20 of Law No. 292, published in the Official Journal La Gaceta , No. 105 of 4 June 1998, and
Article 23 of Decree No. 6-99, Regulation to Law No. 292, Law on Drugs and Pharmacies (Official Journal La
Gaceta , No. 24 of 4 February 1999).