International Update
Ukraine
PETOSEVIC
On 4 July 2013, the State
Administration of Ukraine on
Medicinal Products held a public test
of a new prescription drug monitoring
system aimed at preventing
counterfeit medicines from entering
the supply chain.
The implementation of this system
has been made possible by coating
each drug package with a unique two-
dimensional GS1 DataMatrix barcode.
This system has been tested in the
European Union and recommended
for use by the European Federation of
Pharmaceutical Industries and
Associations (EFPIA).
Ukraine and the EU are planning to
gradually implement the new drug
monitoring system in Ukraine by
2017.
In 2011, the EU published the
Directive No. 2011/62/EU ("the
Falsified Medicines Directive")
according to which drug
manufacturers throughout the EU
need to mark all registered medical
products with a unique identifier. The
Directive came into force in January
2013.
Croatia
PETOSEVIC
Earlier in the summer, the Croatian
Parliament passed the new Law on
Medicines and the new Law on Medical
Devices (Official Gazette No. 76/2013)
under the urgent procedure, ahead of
Croatia's EU accession. The two laws
entered into force in Croatia on 29 June
2013.
The provisions of the former Law on
Medicines, Medicinal Products and Devices
and its amendments (Official Gazettes No.
71/07, 45/09 and 124/11) ceased to have
effect in Croatia after the implementation
of the two new laws.
After 29 June 2013, the Croatian Agency
for Medicinal Products and Medical
Devices initiated procedures to revoke
the approval of marketing authorizations
for medicines granted on the basis of the
former law, and for those for which the
period of data protection has not expired
and which were authorized in the EU by
the centralized procedure (CP).
Accordingly, for medicines or medical
devices approved on the basis of the
former law and for which the approval
will cease to apply in the period from 1
January to 31 March 2014, the marketing
authorization holders (MAHs) need to
submit an application for the renewal of
the approval no later than six months
before the expiration of the marketing
authorization.
Prior to the entry into force of the new
laws, Croatia was obliged to upgrade the
marketing authorization dossiers of the
generics according to the EU acquis
communautaire. Croatia had no
transitional period for applying the rules
of data exclusivity. On the date of
accession, the decisions on the centrally
authorized products applied immediately.
These products, when used as reference
products, are protected for 8 years and
not for 6 years. According to Article 89 of
the Regulation (EC) 726/2004, the data
exclusivity period of "8+2+1" refers only
to those reference products for which the
initial application for granting the
marketing authorization via the CP was
submitted before 20 November 2005.
Therefore, marketing authorizations for
generic products granted on the basis of
reference products for which the data
exclusivity period in the EU (8 or 10
years) has not elapsed will have to be
withdrawn. Also if the market exclusivity
period of 2+1 years for a reference
product has not elapsed, generic products
cannot be on the market until after that
period.
Upon enactment of the new Law on
Medicines on 29 June 2013, data
exclusivity period is now explicitly
governed by a provision of Article 235 of
the new law stipulating that for the initial
applications submitted under the CP from
20 November 2005 onwards, a validity
period of 10 years applies.
With respect to the CP, the decisions on
the centrally authorized products are
extended automatically to Croatia as of 1
July 2013. However, the MAHs have to
provide translations of the product
information in Croatian, in line with the
EU legislation. The MAHs should wait for
the product information linguistic review
(PALC) to be completed before putting
the medicine on the Croatian market.
Croatia can be included in the Mutual
Recognition Procedure (MRP) or the
Decentralized Procedure (DCP) from the
date of accession 1 July 2013 was the
first date that a MRP or DCP application
could have been submitted to Croatia.
Libya
Zeina Salameh, Saba & Co IP
The Trade Mark Office re-opens nearly
two years after its services were
interrupted as a result of the latest civil
unrest in the country. The Office is now
ready to accept search requests and new
trademark applications. All deadlines and
priority dates that fell due within the
closure period will be properly dealt with
to ensure that the files are in order.
The most important change which has
taken place in the country following the
recent events is related to the Libya-
Switzerland relations. Specifically,
Switzerland has recently established
formal diplomatic relations with the Libyan
government after a three-year breakdown
in relations between the two countries.
The implication of this development is
that it will now be possible for Swiss
applicants to file new applications.
Below is a timeline on the major trade
mark-related events that took place in the
country over the past three years that are
worthwhile mentioning:
2009:
The list of goods and services was revised.
The item "veterinary apparatus and
instruments" was added to class 10 and
the item "decorations for Christmas trees
and related products" was removed from
class 28. Also, during the same year, a
Trade Mark Appeal Board was expected
to be established with the main
responsibility of hearing and deciding on
appeals against any rejection decision
issued by examiners in connection with
trade mark applications. This plan was
interrupted due to recent events.
2010:
A new Trade Mark Law was published in
the Local Gazette and became effective in
the country. This law replaces Law no. 40
of 1956. According to the new law, the
definition of a trade mark has been
broadened to include trade names, sound
marks, and color marks. The new law
recognizes famous trade marks that are
well-known in Libya and ensures
protection even if the marks are not
registered. The law also gives the right to
trade mark owners to initiate civil and
criminal actions against any infringing
party. Penalties include a maximum of
two-year imprisonment and payment of
fines of up to US $ 7,500. The
implementing regulations of the new law
have not been issued yet.
2011:
(1) The certified copy of the
corresponding home registration
certificate that was usually required in
support of a trade mark application was
dropped.
(2) The country's official name changed
from "Great Socialist People's Libyan Arab
Jamahiriya" to the more commonly known
name (now official) "Libya". The country's
international code remains the same (LY).
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