Overview
Albania has specific institutions for standardization, conformity assessment, accreditation, and product certification. The Government of Albania has adopted a flexible approach with a mix of voluntary and mandatory standards. 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 International Organization for Standardization (ISO) and European Standards (EN) as primary standards-making bodies based on WTO regulations. These standards supersede all national standards. The General Directorate of Standardization (DPS), the legal entity in charge of standardization in Albania, is responsible to implement European, international, and national standards. The DPS is the National Notification Authority and the National Enquiry Point for WTO and CEFTA for draft standards, draft technical rules, and draft evaluation procedures of conformity with an impact on trade. Based on the 2020 legal amendments, DPS serves also as the National Registration Administrator for Issuers. DPS represents Albania at European and international organizations dealing with standards like CEN, CENELEC, ISO, IEC, ETSI, and ITU and it has been the first public institution in Albania to be certified to ISO 9001. In addition to the voluntary standards, there are also compulsory standards as stipulated in the EU directives which Albania has adopted.
The Law on Standardization No. 9870 established rules and procedures for the development of all national standardization activities and the creation and operation of DPS. The law stipulates the right of voluntary partecipation of all interested parties in the drafting, approval and adoption of Albanian standards and their voluntary implementation. Since its approval in 2008, the law was amended to include standards in all the economic sectors.
Standards
The General Directorate of Standartization is responsible to transpose and publish European and international standards. By 2017, DPS had adopted all harmonized European standards as Albanian standards. Foreign national standards including from the United States are not used in Albania unless adopted by the international organisations that Albania adheres. . DPS publishes quarterly information bulletins, which contain newly adopted standards, withdrawn standards, and standards for public opinion. DPS archive through May 2021, includes 40,400 standarts and standartisation documents of which about 95% are either European or international standards and only 5% are just domestic. DPS has also published the 2021 Albanian standarts catalogue.
Albania is a correspondent member of the International Organization for Standardization (ISO), an affiliate member of the European Committee for Standardization (CEN) and European Committee for Electrotechnical Standardization (CENELEC). Albania is also an associate member to the International Electrotechnical Commission (IEC) and a full member of the European Telecommunications Standards Institute (ETSI). All national standards are adopted in full conformity with European standards (CEN, CENELEC and ETSI standards).
Application of Albanian standards is voluntary and they are identical for both domestic and foreign companies operating in Albania. 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. Every individual or business operating in Albania can be a member of the National Forum of Standardisation that allows them to partecipate in the DPS technical commitees and working groups. In 2020, the most sold standarts were: Bituminous binders, road materials (SSH EN 12697-14: 2020), Aggregates and masonry (SSH EN 1097-2: 2020), Quality ensuring and social responsibility (ISO 13528: 2015), and Water, air and soil quality (SSH ISO 11923: 1997). In addition, 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 remain higly requested by the private sector.
DPS is also the official point of contact for issues related to technical barriers to trade (TBT). Obligations under the WTO sanitary and phytosanitary agreement are passed to the Ministry of Agriculture and Rural Development, and the National Food Authority and the Institute for Food and Veterinary Safety (ISUV) which are the main authorities for the food security in Albania. To import food and agricultural products, companies must receive a license from the National Food Authority. 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 Pharmaceuticals and Medical Equipment (AKBPM) at http://akbpm.gov.al/ is specialized in the analysis, control, and administration of medical equipment standards. AKBPM 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
Law No. 10489, on the trading and monitoring of non-alimentary products defines that private authorized entities can act as conformity assessment bodies in the case of certification, inspection, and testing. The Law also defines procedures for conformity assessment and aims to align Albanian legislation with EU regulations, including EU Regulation 765/2008. According to the law, certificates, tests, and inspection reports, issued by the bodies of conformity assessment in countries outside the European Union, are recognized and accepted in Albania, if these bodies are accredited by an accreditation body signatory of multilateral agreements with the European Organization for Accreditation, the International Organization for the Accreditation of Laboratories or the International Forum of Accreditation. However, it is possible to recognize certificates issued by non-EU bodies if there are equivalent procedures of accreditation.
The primary national conformity assessment body is the General Directorate of Metrology, (DPM). In 2020, a new law on the metrology No. 126/2020 (https://www.parlament.al/Files/Akte/20201020140515ligj%20nr.%20126,%20dt.%2015.10.2020.pdf) was approved. It aims to better unify procedures for conformity assessment, and it sets the obligation that all the non-smart measuring instruments can be imported only until the end of 2022 and used until 2029. DPM implements the metrology policy in Albania in three categories: scientific, industrial, and legal metrology.
DPM 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. Albania recognizes certificates and conformity signs issued abroad if they are in compliance with the international agreement where Albania is a member.
DPM 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.
Product certification is done on a voluntary basis, except in cases of products for security, safety, and the environment when it is compulsory. Most required product certifications concern sanitary characteristics of foodstuffs and medicine. US 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 DPA(http://dpa.gov.al/) and/or foreign Institutions. The Accreditation Directorate is based on the standard SSH EN 45011 for the accreditation of the institutions for product certifications. Since 2016, DPA is a full member of the International Laboratory Accreditation Cooperation and has signed reciprocal recognition agreement which allows that testing certificates issued from accredited laboratories by DPA are equivalent and accepted at international and European level. Accreditation Law 116/2014 on the accreditation of conformity assessment bodies regulates the functioning of the DPA, its accreditation board, its technical committees, and other procedural issues. The General Directorate of Accreditation (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 (EA) Organization. Laboratory accreditation is not compulsory for every sector, but it is mandatory for laboratories dealing with safety and health issues. In April 2018, the DPA became a signatory of the European Cooperation for Accreditation Multi-Lateral Agreement (EA MLA) in the fields of Inspection and Management Systems Certification. 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. Each agency issues its own publications. The DPS publishes a quarterly standards bulletin (in Albanian) and the annual Catalogue of Albanian Standards. Based on Law 9870 “On Standardization” and other bylaws, the General Directorate of Standardization is the WTO/TBT National Notification Authority and Enquiry Point for technical standards, for regulations and for conformity assessment procedures which have an impact on trade. Proposed technical regulations are not widely available to the public. With proposed regulations, however, the DPS will notify WTO officials to solicit comments. Also, twice a year, DPS notifies the ISO / IEC Secretariat of its work program in the framework of the principle of transparency under the WTO / TBT Agreement. The work program contains all the standards that will be adopted within a period of 6 months of the year.
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 (DPS)
Rruga “Reshit Collaku”, (pranë ILDKPKI, kati VI),
Postal Box No: 98, 1001 Tirana, Albania
General Directorate of Standardization
Tel: + 355 (04) 222 6255
E-mail: info@dps.gov.al
National Food Authority
Rruga Stavri Themeli
Tirana 1000, Albania
Phone: +355 (4) 225 6137
National Food Authority
https://aku.gov.al/
E-mail: info@aku.gov.al
National Agency of Pharmaceuticals and Medical Equipment
Rruga e Dibres No. 359/1
Tirana, Albania
+355 (4) 237 6045
National Agency of Pharmaceuticals and Medical Equipment
http://akbpm.gov.al/?lang=en
E-mail: akbpm@shendetesia.gov.al
Accreditation General Directorate
Rruga Durresit, No 27
Tirana 1001, Albania
Phone: +355 (4) 226 9097
E-mail: info@dpa.gov.al
Accreditation General Directorate
http://dpa.gov.al/
General Directorate of Metrology
Address: Autostrada Tirana-Durrës, km 8
Tirana, Albania
Phone: +355 (4) 223 3462
General Directorate of Metrology
E-mail: metrology@dpm.gov.al
Points of Contact at the U.S. Embassy are:
Mr. Alex MacFarlane
Economic & Commercial Officer
United States Embassy
Rruga Elbasanit 103, 1001 Tirana, Albania
tel: +(355) 4 229 3115
e-mail: MacFarlaneAC@state.gov
Ms. Edi Jacellari
Commercial Assistant
United States Embassy
Rruga Elbasanit, 103, 1001 Tirana, Albania
Tel. +355 4 229 3116
E-mail: JacellariE@state.gov
Mr. Frank Nikolla
Economic Assistant
United States Embassy
Rruga Elbasanit, 103, 1001 Tirana, Albania
Tel. +355 4 229 3065
E-mail: NikollaF@state.gov