Describes the country's standards landscape, identifies the national standards and accreditation bodies, and lists the main national testing organization(s) and conformity assessment bodies.

Overview

Albania has specific institutions for standardization, conformity assessment, accreditation, and product certification. In certain areas, such as processed foods, beverages, and pharmaceutical products, individual ministries or agencies issue sector-specific standards and certificates.

 Albania has adopted standards regimes developed in other Western countries with ISO and EN as primary standards-making bodies based on WTO regulations. These standards supersede all national standards. The General Directorate of Standardization (DPS) is the public agency responsible to implement European and international and national standards and is certified according to international standard ISO 9001.

Albania is a correspondent member without voting rights of the International Organization for Standardization (ISO) and an affiliate member without voting rights to the European Committee for Standardization, and European Committee for Electrotechnical Standardization (CEN & CENELEC). Albania is also an associate member to the International Electrotechnical Commission with limited voting rights, and a full member of the European Telecommunications Standards Institute (ETSI). The Stabilization and Association Agreement with the EU stipulates that Albania must adopt European Community technical regulations, European standards, and conformity assessment procedures.

Application of Albanian standards is voluntary unless specified by law. Most standards, aside from those concerning products for human consumption, are not enforced by legislation. Standards are developed or adopted by technical committees composed of interested parties from various sectors and industries. The work of the committees is passed to the national standards organization, the General Directorate of Standardization (DPS), the legal entity in charge of standardization in Albania. DPS represents Albania at European and international organizations dealing with standards like CEN, CENELEC, ISO, IEC, ETSI, and ITU, and serves as a liaison to WTO officials. DPS is also the official point of contact for issues related to technical barriers to trade (TBT). Obligations under the WTO/SPS Agreement are passed to the Ministry of Agriculture and Rural Development and the National Food Authority.

 

Standards

The Law on Standardization No. 9870 established the rules and procedures for the development of all national standardization activities and the creation and functioning of DPS, which is responsible to develop, adopt, approve, implement, and publish Albanian standards in all fields. DPS is also responsible to transpose and publish European and international standards. By 2017, DPS had adopted all harmonized European standards as Albanian standards. Foreign entities should have a local presence to participate in standards development.

DPS publishes quarterly information bulletins, which contain newly adopted standards, withdrawn standards, and standards for public opinion.
The prices of Albanian standards (SSH) are approximately 30% of international standards. Construction-SSH EN 590, oil and gas-SSH EN 228, standards of quality management-SSH EN ISO 9001, and the competency of calibration and testing labs SSH EN ISO/IEC17025 are among the most requested standards by the private sector.

The Ministry of Agriculture and Rural Development: Albania follows WTO agreements on sanitary and phytosanitary procedures. To import food and agricultural products, companies must receive a license from the National Food Authority (AKU). When applicable, products also must pass sanitary, psychopathologic, or veterinary control. Additional information on sanitary requirements can be obtained from the Ministry of Agriculture and Rural Development and the National Food Authority.

The National Agency of Drugs and Medical Equipment (AKBPM) specializes in the analysis, control, and administration of medical equipment standards. NADME operates under the Ministry of Health and works in accordance with WHO principles. It is the licensing authority for drug imports and responsible for drug registration and inspection.
 

Testing, Inspection and Certification


Conformity Assessment

The primary national conformity assessment body is the General Directorate of Metrology, (GDM), which operates in accordance with Law No. 9875, “On metrology.” The GDM implements the metrology policy in Albania in three categories: scientific, industrial, and legal metrology.

GDM develops the national metrology system in line with European standards and harmonizes technical procedures for conformity of measurements to avoid technical barriers to trade. The national metrology system includes national standards laboratories, calibration laboratories, testing laboratories, and certification entities authorized to conduct the business of legal metrology.

The GDM is a member, with full rights of the International Organization of Legal Metrology, of the European Association of National Metrology Institutions, the International Measurement Confederation, and an associate member of the European Cooperation for Legal Metrology, and General Conference on Weights and Measures.

Law No. 10489, on the trading and oversight of non-alimentary products defines that private authorized entities can act as conformity assessment bodies in the case of certification, inspection, and testing.
 

Product Certification

Product certification is done on a voluntary basis, except in cases of exports and products for security, safety, and the environment, in which it is compulsory. Most required product certifications concern sanitary characteristics of foodstuffs and medicine. U.S. exporters generally do not face legal impediments related to product certifications. However, red tape and attempts at corruption could present obstacles during product certification procedures.

The accreditation of product certification is done by the Albanian Accreditation Directorate and/or by foreign Institutions. The Accreditation Directorate is based on the standard SSH EN 45011 for the accreditation of the institutions for product certifications.

In 2015, the European Accreditation Body (EA) General Assembly accepted Albania as a member with full rights. Membership is preconditioned on having an agreement with the EA to become a signatory of the mutual recognition agreements in the field of testing laboratories. This would allow the recognition at the European level of testing by accredited laboratories by the DPA.
 

Accreditation

The Albanian Accreditation Directorate (DPA) is recognized by the Albanian government as the single national accreditation body to assess, in accordance with international standards, organizations that provide certification, testing, and inspection and calibration services. The DPA operates a management system that accords with the requirements of SSH ISO/IEC 17011. The DPA is a full member of the International Laboratory Accreditation Cooperation (ILAC) and of the International Accreditation Forum (IAF) and, since May 2015, a full member of the European Accreditation Organization EA. Laboratory accreditation is not compulsory for every sector. It is, however, mandatory for laboratories dealing with safety and health issues.

Law 116/2014 on the accreditation of organizations that provide conformity assessment in Albania, and Law 10489 for the marketing and monitoring of the non-alimentary market aim to align Albanian legislation with EU regulations, including EU Regulation 765/2008.

In October 2018, DPA signed an agreement with the International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) for the certification of management systems according to ISO 17021-1, which will allow DPA’s certificate to be internationally recognized. Test certificates from foreign laboratories are accepted if the lab is accredited by an EU member state or European accreditation body.
 

Publication of Technical Regulations

Approved technical regulations are published in the Official Gazette, which can be found at the following link: www.qbz.gov.al.

Each agency issues its own publications. The DPS publishes a quarterly standards bulletin (in Albanian) and the annual Catalogue of Albanian Standards. By law, the DPS is the national authority for notifications and a reference for draft standards, technical rules, and procedures for conformity assessment.

Proposed technical regulations are not widely available to the public. With proposed regulations, however, the DPS will notify WTO officials to solicit comments.

NIST Notify U.S. Service
“Members of the World Trade Organization (WTO) are required under the Agreement on Technical Barriers to Trade (TBT Agreement) to notify to the WTO proposed technical regulations and conformity assessment procedures that could affect trade. Notify U.S. (www.nist.gov/notifyus) is a free, web-based e-mail registration service that captures and makes available for review and comment key information on draft regulations and conformity assessment procedures. Users receive customized e-mail alerts when new notifications are added by selected countries and industry sectors of interest and can also request full texts of regulations. This service and its associated web site are managed and operated by the USA WTO TBT Inquiry Point housed within the National Institute of Standards and Technology, part of the U.S. Department of Commerce.”
 

Contact Information

General Directorate of Standardization
Rruga Mine Peza Nr. 143/3
Postal Box 98,
1014, Tirana, Albania
Phone: + 355 (4) 222 6255
Fax: + 355 (4) 224 7177
Email: info@dps.gov.al

National Food Authority
Rruga Muhamet Gjollesha, 56,
Tirana, Albania
Phone: +355 (4) 225 2658
Fax: +355 (4) 225 2658

National Agency of Drugs and Medical Equipment
Rruga e Dibres No. 359/1
Tirana, Albania
+355 (4) 237 6045
E-mail: akbpm@shendetesia.gov.al

Accreditation Directorate
Rruga Sami Frasheri, Nr.33, kati I
Tirana, Albania
Phone: +355 (4) 226 9097 /226 9325
E-mail:info@dpa.gov.al

General Directorate of Metrology
Address: Autostrada Tirana-Durrës, km 8
Tirana, Albania
Phone: +355 (4) 223 3462
Fax: +355 (4) 222 8244
E-mail: metrology@dpm.gov.al

Points of Contact at the U.S. Embassy are:
 Mr. Alexander MacFarlane
Economic & Commercial Officer
United States Embassy
Rruga Elbasanit 103
Tirana, Albania
tel: +(355) (4 229 3115
fax: + (355) (4 2232 222
e-mail: MacFarlaneAC@state.gov

Ms. Edi Jacellari
Commercial Assistant
United States Embassy
Rruga Elbasanit, 103
Tirana, Albania
Tel. +355 (4) 229 3116
Fax: +355 (4) 223 2222
E-mail: JacellariE@state.gov
 
Mr. Frank Nikolla
Economic Assistant
United States Embassy
Rruga Elbasanit, 103
Tirana, Albania
Tel. +355 (4) 229 3065
Fax: +355 (4) 223 2222
E-mail: NikollaF@state.gov

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