{"id":19566,"date":"2022-11-08T10:46:05","date_gmt":"2022-11-08T09:46:05","guid":{"rendered":"https:\/\/anpp.dz\/regulatory-texts-relating-to-pharmaceutical-products\/"},"modified":"2026-03-13T17:14:37","modified_gmt":"2026-03-13T16:14:37","slug":"regulatory-texts-relating-to-pharmaceutical-products","status":"publish","type":"page","link":"https:\/\/anpp.dz\/en\/regulatory-texts-relating-to-pharmaceutical-products\/","title":{"rendered":"Regulatory Texts Related to Pharmaceutical Products"},"content":{"rendered":"

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<\/i> Decree of 16 Jumada al-Ula 1443, corresponding to December 21, 2021, amending the Decree of 11 Jumada al-Ula 1442, corresponding to December 26, 2020, concerning the appointment of the president and members of the Pharmaceutical Product Registration Committee for human use.<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

Decree of 17 Jumada al-Ula 1443, corresponding to December 22, 2021, amending the Decree of 11 Jumada al-Ula 1442, corresponding to December 26, 2020, concerning the appointment of the president and members of the Intersectoral Economic Committee for Medicines.<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/jo-francais\/2022\/F2022008.pdf#page=38″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

<\/i> Decree of 27 Safar 1443, corresponding to October 4, 2021, establishing the procedures for registering locally manufactured pharmaceutical products intended exclusively for export.<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/JO-francais\/2021\/F2021083.pdf?znjo=83#page=27″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

<\/i> Decree of 27 Safar 1443, corresponding to October 4, 2021, defining the exemption criteria for generic and similar biotherapeutic medicines from bioequivalence studies and other therapeutic equivalence tests, as well as the list of these medicines.<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/JO-francais\/2021\/F2021087.pdf#page=22″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

<\/i> Decree of 26 Safar 1443, corresponding to October 3, 2021, establishing the procedures for modifying the registration decision for pharmaceutical products for human use.<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/JO-francais\/2021\/F2021087.pdf#page=22″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

<\/i> Decree of 26 Safar 1443, corresponding to October 3, 2021, defining the procedures for reviewing registration applications and the template for the pre-submission form for pharmaceutical products.<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/JO-francais\/2021\/F2021087.pdf#page=22″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

<\/i> Decree of 12 Dhu al-Hijjah 1442, corresponding to July 22, 2021, establishing the procedures for registering imported pharmaceutical products that are registered but not marketed in their country of origin.<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/JO-francais\/2021\/F2021087.pdf#page=22″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

<\/i> Decree of 28 Ramadan 1442, corresponding to May 10, 2021, defining the contents of the registration file and the renewal file for the registration decision.<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/jo-francais\/2021\/F2021055.pdf?fbclid=IwAR0eAY_osOTih1LxX69yCEd5_sg2JOef639usErj4MIZztNmmfmxbBhduOo#page=27″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

<\/i> Decree of 2 Rajab 1442, corresponding to February 14, 2021, establishing the technical specifications for the importation of pharmaceutical products and medical devices for human use.<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/JO-francais\/2021\/F2021015.pdf?znjo=15#page=17″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

<\/i> Decree of 23 Jumada al-Ula 1442, corresponding to January 7, 2021, amending the Decree of 11 Jumada al-Ula 1442, corresponding to December 26, 2020, concerning the appointment of the president and members of the Pharmaceutical Product Registration Committee for human use.<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/JO-francais\/2021\/F2021011.pdf?znjo=11#page=35″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

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<\/i> Decree of 11 Jumada al-Ula 1442, corresponding to December 26, 2020, concerning the appointment of the president and members of the Pharmaceutical Product Registration Committee for human use.<\/a><\/h6>\n<\/div>\n<\/div>\n<\/div>\n
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<\/i> Decree of 11 Jumada al-Ula 1442, corresponding to December 26, 2020, establishing the template for the pre-submission form for pharmaceutical product registration applications.<\/a><\/h6>\n<\/div>\n<\/div>\n<\/div>\n
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Decree of 12 Jumada al-Ula 1442, corresponding to December 27, 2020, defining the contents of the registration file for medicines for human use.<\/a><\/h6>\n<\/div>\n<\/div>\n<\/div>\n
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<\/i> Decree of 12 Jumada al-Ula 1442, corresponding to December 27, 2020, concerning the missions, composition, organization, and functioning of the Clinical Experts Committee.<\/a><\/h6>\n<\/div>\n<\/div>\n<\/div>\n
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<\/i> Decree of 11 Jumada al-Ula 1442, corresponding to December 26, 2020, establishing the procedure for documentary and\/or technical evaluation of registration files and the list of relevant medicines.<\/a><\/h6>\n<\/div>\n<\/div>\n<\/div>\n
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[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/JO-francais\/2020\/F2020078.pdf#page=31?znjo=78″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

<\/i> Decree of 11 Jumada al-Ula 1442, corresponding to December 26, 2020, concerning the appointment of the president and members of the Intersectoral Economic Committee for Medicines<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/JO-francais\/2020\/F2020078.pdf#page=33?znjo=78″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text]<\/p>\n

<\/i> Decree of 11 Jumada al-Ula 1442, corresponding to December 26, 2020, establishing the procedure for setting medicine prices by the Intersectoral Economic Committee for Medicines.<\/a><\/h6>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″ onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/www.joradp.dz\/FTP\/JO-francais\/2020\/F2020078.pdf#page=33?znjo=78″][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

[vc_row css=”.vc_custom_1667901183045{background-color: #fdf6ed !important;}”][vc_column width=”5\/6″][vc_column_text] Decree of 16 Jumada al-Ula 1443, corresponding to December 21, 2021, amending the Decree of 11 Jumada al-Ula 1442, corresponding to December 26, 2020, concerning the appointment of the president and members of the Pharmaceutical Product Registration Committee for human use. [\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_single_image image=”17930″][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1667901209296{margin-top: 20px !important;margin-bottom: 20px !important;background-color: #fdf6ed […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-19566","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/pages\/19566","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/comments?post=19566"}],"version-history":[{"count":2,"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/pages\/19566\/revisions"}],"predecessor-version":[{"id":22084,"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/pages\/19566\/revisions\/22084"}],"wp:attachment":[{"href":"https:\/\/anpp.dz\/en\/wp-json\/wp\/v2\/media?parent=19566"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}