Training Course

Module LITHUANIA

Main EU requirements in Lithuanian legal acts• Law on Pharmacy/ provisions of Directive 2001/83/EC on placing of MP on themarket, granting of Marketing Authorizations, Clinical trials, Pharmacovigilance,Licensing of activities with MP and etc.

• Rules on Licensing of Pharmaceutical Activities/ provisions of Directive2001/83/EC on Licensing procedure, Types of licenses, Formats of licenses,Requirements for QP;

• The good pharmacy practice (GPP) approved by the Minister of Health

• The requirements for pharmacy’s premises and equipments approved by theMinister of Health

• European Parliament and Council directives(2001/83 EB; 2011/62/ES – regarding the prevention of counterfeit medicines entering the legal supply chain of medicines)

•ES guidelines

CURRENT LEGAL SITUATION

«Medicinal products manufactured industriallyor by a method involving an industrial processmay be supplied to the market of the Republic ofLithuania only if registered in the Register ofMedicinal Products of the Republic of Lithuania,in the Community Code of Medicinal Products orentered in the List of Parallelly ImportedMedicinal Products»

Loreta Adomonytė

LITHUANIAN PHARMACY LAW ONREGISTRATION ON MEDICINAL PRODUCTS

• Medicinal products - subject to medical prescription - shallbe dispensed (sold) to patients undergoing outpatienttreatment only on the doctors’ prescription;

• Medicinal products shall be sold to the residents onlythrough pharmacies;

• Medicinal products must be supplied with Lithuanianpackages, whether they are monolingual or multilingualpackaging labelling;

Loreta Adomonytė

LITHUANIAN PHARMACY LAW ONSELLING THE MEDICINAL PRODUCTS

• Today trade of medicines through the internet isnot allowed in Lithuania.

• According to GPP it is legal to order prescriptionand non-prescription medicines by the phone orthrough the internet website. But medicines couldbe dispensed and should be paid for them only in apharmacy. Pharmacy specialist should providepharmaceutical services. If a prescription medicineis ordered, an individual must provide a prescriptionin a pharmacy.

CURRENT LEGAL SITUATION

Since 2008 online pharmaceutical service is provided in Lithuania– medicines and medicine supplements can be ordered online

• Major pharmacy chains and the largest wholesale companieshave their own online pharmacies in Lithuania:

• www.vaistine.lt – pharmacy chain “Gintarine vaistinė”;• http://evaistine.camelia.lt – pharmacy chain “Camelia

vaistinė”;• www.100metu.lt – wholesaler UAB “Armila”;• www.mano-vaistine.lt – wholesaler UAB “Entafarma”;• www.efarma.lt – UAB “Efarmos” vaistinė;• http://univaistine.lt – LUHS pharmacy

ONLINE PHARMACEUTICAL SERVICE

• The pharmacy law of the Republic of Lithuania (2013.06.18addition) was supplemented with a new article

“Main requirements for offering to sell medicines remotely”

• Will come into effect 1 year after Directive 2011/62/EU will befully implemented

THE FORTHCOMING LEGAL SITUATION (I)

• Medicine can only be sold in pharmacies, according to theprocedure of the Ministry of Health

• Medicines can only be collected at the pharmacy or delivered tothe resident's preferred location

• All pharmacies must inform SMCA by giving notice of thedetermined form before starting online trade

• Only registered non-prescription medicine can be offered to besold remotely

MAIN REQUIREMENTS (1)

• To offer to sell medicinal products by remote way also have theright entities established in the other countries of the EEA(European Economic Area)• It is permitted to offer to sell in the other country of EEA onlythose medicinal products for which marketing authorisation isgranted in that EEA country and which are over-the-countermedicinal products• Logotype of general design established by EuropeanCommission must be clearly seen on the internet webpage andappropriate information must be provided

MAIN REQUIREMENTS (2)

Lithuanian legal acts which were amended in 2013relating to the implementation of Directive (2011/62/ES)on falsified medicinal products:1. The Law on Pharmacy2. Two Orders of the Minister of Health:a) Amendments to the good pharmacy practiceb) The list of information related to the offer for sale at a distanceto the public by means of information society services whichshould be provided in website of the State Medicines ControlAgency

THE FORTHCOMING LEGAL SITUATION (II)

Provisions regarding a sale at a distance to the public laiddown in above mentioned legal acts will come into forceafter 1 year after the date of the publication of theEuropean Commission acts implementing the Article 85cof the Directive 2001/83 regarding the common logo andrequirements for verification of the authenticity of it

THE FORTHCOMING LEGAL SITUATION (III)

The main forthcoming requirements for thetrade through the internet in Lithuania (I)• Only pharmacies will have the right to sell medicines at

a distance to the public. Also this right will be given toentities established in the other country of the EEAwho will have the right to sell medicines at a distance inthat country

• Not longer than 14 days before beginning of thisactivity a pharmacy has to inform the State MedicinesControl Agency by giving notice of the determined form

MAIN REQUIREMENTS (1)

The main forthcoming requirements for thetrade through the internet in Lithuania (II)• Only registered non-prescription medicines could besold at a distance to the public in Lithuania

• Medicines sold to other country of the EEA should beregistered non-prescription medicines according to thenational law of that country

• Medicines sold at a distance could be collected in apharmacy or delivered to the individual’s preferredlocation

MAIN REQUIREMENTS (2)

The main forthcoming requirements for thetrade through the internet in Lithuania (III)• When pharmacies will start selling medicinal products ata distance, a pharmacy specialist will start providingpharmaceutical services by means of information societyservices

• A common logo, adopted by the European Commission,identifying websites which are legally offering medicinesfor sale should be clearly seen on an every pharmacy’swebsite page. Also an appropriate informationdetermined by the Minister of Health should be provided

MAIN REQUIREMENTS (3)

The main forthcoming requirements for thetrade through the internet in Lithuania (IV)

• Detailed rules regulating a sale at a distance will beestablished by the Minister of Health

MAIN REQUIREMENTS (4)

1. Detailed legal rules which will determine a sale at adistance

2. The adoption of the implementing acts which theEuropean Commission shall adopt in regard to thecommon logo

FUTURE TASKS FOR THE MINISTRY OFHEALTH OF LITHUANIA

There are illegal and unlicensed internet websites - medicines, foodsupplements, medicinal products, anabolic steroids, psychotropic drugs,and other are offered to be bought through the internet

FIGHT AGAINST TRADE OF FAKEMEDICINE TROUGHT INTERNET (I)

Current legislation on liability in theRepublic of Lithuania:

• 3 kinds of liability:- Criminal- Administrative- Civil

LEGAL LIABILITY FOR VIOLATIONS (I)

Grounds for imposition of criminal and administrative liabilityto IPR-related crimes:

• Marking of goods with another’s trademark without holding anauthorization

• Handling or submission for handling of goods marked by another’strademark

• Transportation of goods marked with another’s trademark for the purposesof acquiring pecuniary benefit

• Storage of goods marked with another’s trademark for the purposes ofacquiring pecuniary benefit

LEGAL LIABILITY FOR VIOLATIONS (II)

Administrative liability for:• Article 43 (10):Violation of regulations and other legal acts of medical

device safety, quality, performance, operation and marketing• Artivle 44: Iligal acquisition or possesion of narcotic drugs and

psychotropic substances in small quantities or use of narcotic drugs orpsychotropic substances use without a doctor's appointment -;

• Article 44 (1): Illegal engagement in drugs and (or) medical productsrelated activities

• Article 44 (2): Violation of legislation governing activities related to narcoticdrugs or psychotropic substances precursors

• Article 44 (3): Violation of Pharmacy Practice and activities rulles relatedto medicines (drugs), and (or) medical products

• Article 44 (6): Violation of of medical products marketing regulations

The code of administrative infringements of law

LEGAL LIABILITY FOR VIOLATIONS (III)

Criminal liability for:

• Undertaking economic, commercial, financial orprofessional activities in the form of a business or on alarge amounts without holding a license to engage in theactivities for which it is required or by other unlawfulmeans

The criminal code article 202

LEGAL LIABILITY FOR VIOLATIONS (IV)

Criminal liability for:

• The sale of medicines who were manufacturedwithout an authorization for the purpose of handlingthem. With condition that the use of these medicinescould have caused a threat to human health or life orhave resulted in a person’s death or a serious injury.

The criminal code article 275

LEGAL LIABILITY FOR VIOLATIONS (V)

Criminal liability for:• Infringing exclusive owner of the patent or designrights or legal entity right to it’s name

The criminal code article 195

The criminal code article 204

Criminal liability for:• Marking large quantity of goods with someonestrademark without permision or pacing them to market orusing someones else trademark and by this act cousingdamages

LEGAL LIABILITY FOR VIOLATIONS (VI)

Control of illegal online trade or trade of fake medicineinvolves different actors:• Institutions• Law enforcements• Customs

FIGHT AGAINST TRADE OF FAKEMEDICINE THROUGH INTERNET (II)

STATE MEDICINES CONTROL AGENCY (SMCA) – theGovermental Body under the Ministry of Health

which is financed by State budget

The purpose of SMCA is to protect public healthassessing the quality, safety, efficacy of medicinalproducts (MP) for human use, controlling of activityof licensed companies and pharmacists andsupervising of MP’s market

STATE MEDICINES CONTROLAGENCY (SMCA)

• The scientific evaluation of marketing authorisationaplications and granting of marketing authorisations;• The granting permits and supervision of clinical trials ofMP;• The supervision of safety of MP by monitoring through apharmacovigilance network;• The supervision of activity of manufacturers, importers,wholesale distributors and pharmacies (by licencing andrepeated inspections);• The control of quality MP placing in the market (samplingand testing in the SMCA laboratory);• The supervision of legal turnover of narcotic andpsychotropic substances and MP;• The supervision of advertising, selling and pricing of MP,etc.

THE MAIN RESPONSIBILITIES OF SMCA

• Assessing of applications of companies seeking licences formanufacture and wholesale distribution activities;• Taking conclusions to grant, suspension or revocation of licences;• Inspecting of licensed companies to follow legal requirements;• Assessing their compliance with GMP, GDP, GPP requirements;• Assessing clinical trials compliance with GCP requirements;• Control storage of MP in Health Care Institutions;• Sampling of API and MP and taking for testing;• Handling of imformation about suspected quality defects;• Taking proposals to recall defective MP from the market;• Handling Rapid Alerts and Recalls from the market and etc.

RESPONSIBILITIES OF THE INSPECTORSUNIT (I)

• SMCA controls legal entities and legal medicineproducts, but does not control illegal trade orfake medicine.• Control of illegal trade is in police and customscompetence• SMCA Inspection Unit specialists cooperatewith police by: providing information, consultingabout medicines, sometimes testify as experts incourts.

RESPONSIBILITIES OF THE INSPECTORSUNIT (II)

- Customs is the leading authority for controlof and the fight against illegal trade in goods

- Appearance of new types of fraud / crimeand modus operandi along with the growingcomputerisation of the society

- Internet is a perfect virtual market place

FIGHT AGAINST TRADE OF FAKEMEDICINE THROUGH INTERNET (III)

New subdivision in Customs Criminal Service of the Republic ofLithuania with a purpose to fight against the Internet crime inthe area of customs competence:

• Acquisition of equipment technical and software equipmentwhich is needed for internet monitoring and investigation• Analysis of legal acts• Drafting cooperation agreements with public and private sector• Specific training for customs officers• CCWP project group regarding cybercrime in customs matters

FIGHT AGAINST TRADE OF FAKEMEDICINE THROUGH INTERNET (IV)

Legislation of customs responsibilities:

• Regulation (EU) No 608/2013 of the European Parliament and of the Councilof 12 June 2013 concerning customs enforcement of intellectual propertyrights and repealing Council Regulation (EC) No 1383/2003

• Commission Implementing Regulation (EU) No 1352/2013 of 4 December2013 establishing the forms provided for in Regulation (EU) No 608/2013 ofthe European Parliament and of the Council concerning customs enforcementof intellectual property rights

• Law of the Republic of Lithuania on CustomsChapter VII. Protection of intellectual property on import and export of goods

FIGHT AGAINST TRADE OF FAKEMEDICINE THROUGH INTERNET (V)

120

14

32

0

50

100

150

Vilnius Airport Customspost

Vilnius Post of the PostOffice

Other customs posts

SEIZURE OF GOODS INFTINGING INTELECTUALPROPERTY RIGHTS IN LITHUANIA IN 2013

• Fake medicines (most often medicines totreat erectile dysfunction, foodsupplements to reduce weight containingsibutramine, etc.) bought via Internet inthe third countries

• These goods physically delivered into theRepublic of Lithuania by expressconsignments and postal parcels

• Sold in internal market via the Internet orin public market places

MODUS OPERANDI USED

- Internet as a communicationtool affording a high level ofanonymity and interfering withconventional law enforcementinvestigation methods

- Goods are physicallydelivered / transported inviolation of EU and nationalcustoms laws

- No crime is as borderless ascybercrime

FIGHT AGAINST TRADE OF FAKEMEDICINE THROUGH INTERNET (VI)

WCO

- Regular and targetedcustoms inspections at thecustoms posts of entry intothe EU and postal hubs

- Participation in various JointCustoms Operations (e.g.,Pangea, Ermis, etc.)

CCWP

FIGHT AGAINST TRADE OF FAKEMEDICINE THROUGH INTERNET (VI)

Action 7.3" To examine the working/investigative techniques applied by customs andother law enforcement authorities to combat customs related crime, includingorganized crime, through the Internet, and to explore the current situationregarding the existence of customs specialised units dealing with those crimesand to ensure follow-up to Action 5.2.."

The purpose of this action:- Assist the Member States which plan to set up a structure within Customsauthorities which would deal with monitoring of customs-related Cybercrime- Share experience and exchange of best practices- Improve cooperation between existing specialized customs cybercrime units

CCWP PROJECT GROUP REGARDINGCYBERCRIME IN CUSTOMS MATTERS

CCWP PROJECT