|
Country
|
Protection
Term
|
Highlights
|
Country
|
Protection
Term
|
Highlights
|
|
Canada
|
5
years
|
Food
and Drug Regulations, Section C.08.004.1
|
Hungary
|
6
or 10 years
|
Health
Ministeral Decree 12/2001 on Registration and marketing approval
of drugs for Human use - Section 26
|
|
Mexico
|
5
years
|
Article
1711. Trade Secrets, NAFTA
|
Latvia
|
6
or 10 years
|
Normative
Documentation of Republic of Latvia Pharmacy Regulations,
Article 18-20
|
|
USA
|
5
years
|
Food
and Drug Law. Section 505 (355) (D)
|
Poland
|
3
years
|
Act
of 6 September 2001, Pharmaceutical Law Article 15.1.
|
|
Costa
Rica
|
5
years
|
Article
9-- Abbreviated documentation for the Authorisation of a Pharmaceutical
Preparation. Article 10 - Mandatory Licenses after the Expiration
of the Period. Article 11-- Definition of an Essentially similar
Medication. Article 12-Documentation and Data Exclusivity
compliance
|
Romania
|
6
or 10 years
|
Draft
Reglementation Law
|
|
El
Salvador
|
Not
specified
|
Article
177 and 178 of Law of the Development and Protection of Intellectual
Property
|
Russia
|
Not
specified
|
Article
39-Civil Code-Business or Commercial Secret
|
|
Guatemala
|
15
years
|
Article
177 --Industrial Property Law; Governmental Agreement no.
89-2002 Article 87 " Protection of evidence or other information.
|
Slovak
Republic
|
6
years
|
Coll.
On Drugs and Sanitation Facilities
|
|
Honduras
|
Not
specified
|
Industrial
Property Law, Article 73 and 74
|
Slovenia
|
6
years
|
Article
15, Medical Act
|
|
Nicaragua
|
Not
specified
|
Article
125 -- Industrial Property Law,
|
Bulgaria,
Croatia, -----
|
|
No
39.3 Data Protection
|
|
Panama
|
10
years
|
Legislative
Assembly Law no. 23; Section 7 : Protection of undisclosed
information - Article 39
|
Lithuania
|
|
|
|
Trinidad
&
|
Not
specified
|
Article
27/1996-Protection against unfair
|
Egypt
|
5
years
|
Peoples
Assembly Committees Undisclosed Information - Articles 55-62,
Prime Minister Decree No. 1211 Concerning Data Exclusivity
of Chemical , Agricultural and Pharmaceutical Products
|
|
Tobago
|
|
competition
|
Jordan
|
5
years
|
Article
(8) - Unfair Competition Law
|
|
Cuba;
|
----
|
No
39.3 data protection
|
Saudi
Arabia
|
Not
specified
|
Provides
defact Article 39.3 protection; no separate legislation
|
|
Dominican
|
|
|
South
Africa
|
Not
specified
|
Medicines
Control Act 101 of 1995, Section 34
|
|
Republic
|
|
|
Kenya,
|
-----
|
No
39.3 Data Protection
|
|
Bolivia
|
5
years
|
Andean
Pact Article 266 of decision 486 dated 12/1/2000
|
Morocco,
|
|
|
|
Brazil
|
Not
specified
|
Chapter
VI crimes of unfair competition Article 195
|
Nigeria
|
|
|
|
Colombia
|
5
years
|
Andean
Pact Article 266 of decision 486 dated 12/1/2000
|
Australia
|
5
years
|
Data
Exclusivity Provision of the Therapeutic Goods Act(Cth) 1989
(Australia) .25A
|
|
Colombia;
|
Not
specified
|
Treaty
of the group of three. Article 18-22:
|
China
|
6
Years
|
Implementing
Regulation of Drug Administration Law of China Article 31
- Draft of February 19, 2002; Report of Working Party on Accession
of China to WTO.
|
|
Mexico
&
|
|
Data
Protection of Chemicals used for
|
Hong
Kong
|
Not
specified
|
Pharmacy
and Ordinance Act
|
|
Venezuela
|
|
Pharmaceutical
Purposes or Agrochemicals.
|
Japan
|
6
years
|
Japanese
Drug Regulation Article 18-3
|
|
Ecuador,
Peru,
|
5
years
|
Andean
Pact Article 266 of decision 486
|
Korea
|
4
or 6 years
|
Article
26-2 of the PAL; Article 5, Paragraph 11 of the KFDA Regulations
Regarding the Safety and Efficacy Examination of Drug Products.
|
|
Venezuela
|
|
dated
12/1/2000
|
New
Zealand
|
5
years
|
23B.
Medicines Act 1981
|
|
Argentina,
Chile,
|
------
|
No
39.3 data protection
|
Pakistan
|
Not
specified
|
Drugs
Act 1976. Section 43 of the Drugs Act.
|
|
Paraguay,
|
|
|
Singapore
|
5
years
|
Medicines
(amendment) Act of 1998; New Sections 19A and 19B
|
|
Uruguay
|
|
|
Thailand
|
Not
specified
|
Trade
Secret Act Chapter 3, Section 15
|
|
Austria,
|
6
years
|
|
India,
|
----
|
No
39.3 Data Protection
|
|
Denmark,
Finland,
|
|
|
Indonesia,
|
|
|
|
Greece,
Iceland,
|
|
|
Malaysia,
|
|
|
|
Ireland,
Norway,
|
|
|
Philippines,
|
|
|
|
Portugal,
Spain
|
|
|
Taiwan
|
|
|
|
Switzerland
|
5
years
|
Decree
on Medications; Section 3, Article 17
|
|
|
|
|
Turkey
|
Not
specified
|
Annex
8 on Protection of Industrial and Commercial Property of the
Customs Union Agreement.
|
|
|
|
|
Czech
Republic
|
6
years
|
Section
32 of Law No. 79/1997 Coll. On Drugs
|
|
|
|
|
Estonia
|
6
years
|
Article
2- Submission of Application for marketing Authorisation Article
2.5
|
|
|
|
|
[Source:
Publication of the International Federation of Pharmaceutical
Manufacturers Association, July 2002]
|
