of 26 July 2022amending the regulation on the list of active substances contained in medicinal products, which may be authorized in non-pharmacy outlets and pharmacy outlets, and on the criteria for classifying these products into individual listsBased on Article.71 sec.3 points 1 and 2 of the Act of 6 September 2001 - Pharmaceutical Law (Journal of Laws of 2021, items 1977 and 2120 and of 2022, items 830, 974, 1095 and 1344), the following is ordered :§ 1. In the Regulation of the Minister of Health of 21 December 2021 on the list of active substances included in medicinal products that may be admitted to trading in non-pharmacy outlets and pharmacy outlets, and the criteria for classifying these products to individual lists (Journal U. of 2022, item 208), the following changes shall be introduced: 1) in Annex 1 to the Regulation: a) in sec.1: - point 2 shall read as follows: "2) the list of medicinal products authorized in pharmacy outlets shall include medicinal products containing the following active substances: a) Duloxetinum, b) Hydroxyzinum, c) Piracetamum, d) Vinpocetinum;", - in point 6 is replaced by a semicolon and the following point 7 is added: "7) the list of medicinal products authorized in pharmacy outlets shall include medicinal products containing a standardized suspension of Escherichia coli bacterial culture.", b) Table 1 "List of substances active, which may be in the form of various salts and isomers, esters, ethers or their salts (salts of isomers, esters and ethers), which are included individually or in combination in medicinal products authorized in pharmacies ": - po lp.237, the following is added:237a is added: 237a Doxylamine - after no.344 is added 1p.344a is added: 344a Insulinum degludecum - after no.634 is added 1p.634a, reading: 634a Semaglutidum c) in Table 3 "Plant starting materials for the production of herbal active substances included in medicinal products authorized for marketing in pharmacy outlets. Herbal active substances may be in the form of herbal preparations or in their combinations": - after No.4, the following item is added.4a reading as follows: 4a Allii cepae bulbus - after No.6, the following item is added.6a is added: 6a Aloe ferox - item no.11 is replaced by the following: 11 Angelicae archangelicae radix (Archangelicae radix) - no.14 is replaced by the following: 14 Arnicae flos (Arnicae anthodium) - no.16 is replaced by the following: 16 Artemisiae abrotani herba - after No.41, the following is added:41a is added: 41a Citrus aurantium - after no.42, the following item is added.42a is added: 42a Cnici benedicti herba - no.47 is replaced by the following: 47 Crataegi folium cum flore (Crataegi inflorescentiae) - after No.57 the following item is added.57a is added: 57a Epilobii angustifolii herba - no.66 is replaced by the following: 66 Fucus vel Ascophyllum (Fucus) - item no.67 is replaced by the following: 67 Fumariae herba - item no.84 is replaced by the following: 84 Iberis amara herba - after No.89, the following item is added.89a and 89b as follows: 89a Lecithinum soiae 89b Leonuri cardiacae herba - no.94 is replaced by the following: 94 Lupuli flos (Lupuli strobilus) - item no.96 is replaced by the following: 96 Melaleuca quinquenervia - item no.127 is replaced by the following: 127 Plantaginis lanceolatae herba - item no.131 is replaced by the following: 131 Populi cortex - no.137 is replaced by the following: 137 Psyllii semen - no.147 is replaced by the following: 147 Rubi idaei folium - item no.163 is replaced by the following: 163 Solidaginis virgaureae herba - after No.164 is added lp.164a is added: 164a Tanaceti herba - no.165 is replaced by the following: 165 Tanaceti parthenii herba - after no.165, the following is added:165a is added: 165a Taraxaci herba - no.184 is replaced by the following: 184 Violae herba cum flore (Violae tricoloris herba) 2) in Annex 2 to the Regulation: a) in the title of the Annex, the word "skepach" shall be replaced by the word "shops", b) in sec.1 in point 1 in lit.and after the thirty-seventh indent the thirty-eighth indent is added as follows: "- antiparasitic agents (P03A),", c) in Table 1 "Plant starting materials for the production of herbal active substances included in medicinal products authorized for marketing in herbal stores -medicals. Herbal active substances may be present in the form of plant preparations or in their combinations ": - in item no.4, the following item is added.4a reading as follows: 4a Allii cepae bulbus - after No.6, the following item is added.6a is added: 6a Aloe ferox - item no.11 is replaced by the following: 11 Angelicae archangelicae radix (Archangelicae radix) - no.14 is replaced by the following: 14 Arnicae flos (Arnicae anthodium) - no.16 is replaced by the following: 16 Artemisiae abrotani herba - after No.41, the following is added:41a is added: 41a Citrus aurantium - after no.42, the following item is added.42a is added: 42a Cnici benedicti herba - no.47 is replaced by the following: 47 Crataegi folium cum flore (Crataegi inflorescentiae) - after No.57 the following item is added.57a is added: 57a Epilobii angustifolii herba - no.66 is replaced by the following: 66 Fucus vel Ascophyllum (Fucus) - item no.67 is replaced by the following: 67 Fumariae herba - item no.84 is replaced by the following: 84 Iberis amara herba - after No.89, the following item is added.89a is added: 89a Leonuri cardiacae herba - no.94 is replaced by the following: 94 Lupuli flos (Lupuli strobilus) - item no.96 is replaced by the following: 96 Melaleuca quinquenervia - item no.127 is replaced by the following: 127 Plantaginis lanceolatae herba - item no.131 is replaced by the following: 131 Populi cortex - no.137 is replaced by the following: 137 Psyllii semen - no.147 is replaced by the following: 147 Rubi idaei folium - item no.163 is replaced by the following: 163 Solidaginis virgaureae herba - after No.164 is added lp.164a is added: 164a Tanaceti herba - no.165 is replaced by the following: 165 Tanaceti parthenii herba - after no.165, the following is added:165a is added: 165a Taraxaci herba - no.184 is replaced by the following: 184 Violae herba cum flore (Violae tricoloris herba) d) in Table 2 "List of substances authorized for marketing in herbal and medical stores, which may be combined with one or more plant material or their preparations , provided that they meet the requirements of Table 3 ": - item no.46 is replaced by the following: 46 Carbo medicinalis (Carbo activatus) - item no.136 is replaced by the following: 136 Propanolum e) in Table 3 "Requirements for the composition, pharmaceutical form, strength and content of active substances in the packaging of a medicinal product or the packaging size of a medicinal product for medicinal products that may be marketed in herbal and medical stores. ": - lp.5 is replaced by the following: 5 Acidum acetylsalicylicum + Acidum ascorbicum, solid oral forms 500 mg + 300 mg 6,000 mg + 3,600 mg - item no.20 is added lp.20a and 20b as follows: 20a Aloes arborescentis recentis extractum fluidum + Acidum ascorbicum syrup 1 920 mg + 51 mg / 5 ml 76.8 g + 2.04 g 20b Aloes extractum siccum + Boldinum solid oral forms 3.60-4 , 40 mg of hydroxyanthracene derivatives expressed as barbaloin + 1.0 mg 708 mg + 30 mg - lp.26 is replaced by the following: 26 Aluminii hydroxidum cum Magnesii carbonate gelatum desiccatum + Magnesii hydroxidum solid forms for oral or oral administration 450 mg + 300 mg 10 800 mg + 7 200 mg - item no.31, the following is added:31a and 31b as follows: 31a Benzocainum + Extractum compositum spissum ex: Arnica herba, Thymi herba, Salviae folium, Calami rhizoma, Matricariae flos, Menthae piperitae herba, Quercus cortex oral fluid 2 g + 50 g / 100 g 0 , 5 g + 12.5 g 31b Benzocainum + Matricariae extractum spissum, Belladonnae radicis extractum spissum, Extractum compositum spissum ex: Cytisi scoparii herba, Hippocastani cortice, Tormentillae rhizoma, Millefolii herba rectal pharmaceutical forms 100 mg + 50 mg + 11.12 -20 mg + 80 mg 1 200 mg + 600 mg + 134.4-240 mg + 960 mg - no.42-44 are replaced by the following: 42 Calcii carbonas + Magnesii carbonas solid forms for oral or oral administration 700 mg + 100 mg 67 200 mg + 9 600 mg 43 Calcium (Calcii carbonas, Calcii glubionas, Calcii gluconas, Calcii lactobionas, Calcii lactogluconas, Calcii oxidum, Calcii phosphas) ​​solid oral or oral forms 500 mg Ca2 + 50,000 mg Ca2 + 44 Carbo medicinalis (Carbo activatus) solid oral forms 300 mg 6,000 mg - item no.51, the following is added:51a and 51b as follows: 51a Convallariae extractum fluidum + Crataegi foil cum flore extractum fluidum + Troxerutinum liquid forms for oral administration (0.47 g + 0.4 g, 4.7 mg) / 1 ml 40 g 51b Crataegi cum Valerianae tinctura + Convallariae tinctura titrata + Colae seminis extractum fluidum + Coffeinum liquid forms for oral administration (360 mg + 250 mg + 130 mg + 0.655 mg) / 1 ml 40 g - no.55, - No.67 is replaced by the following: 67 Etofenamatum semi-solid pharmaceutical forms for application to the skin or mucous membranes 100 mg / g 100 g liquid pharmaceutical forms for application to the skin or mucous membranes 100 mg / ml 50 ml - item no.67, the following is added:67a as follows: 67a Extractum spissum compositum (4-6: 1) + Chamomillae extractum + Natrii citras + Kalii citras + Vitis idaeae folium extractum + Phaseoli pericarpium solid oral forms 86.2 mg + 78 mg + 19 mg + 16 mg + 16 mg + 8 mg 5 172 mg + 4 680 mg + 1 140 mg + 960 mg + 480 mg - po.71, the following is added:71a-71c as follows: 71a Hippocastani seminis extractum siccum + Rutosidum trihydricum + Aesculinum solid forms for oral administration 25 mg + 15 mg + 0.5 mg 750 mg + 450 mg + 15 mg 71b Hippocastani seminis extractum siccum + Rutosidum trihydricum solid forms for oral administration 100 mg + 60 mg 3,000 mg + 1,800 mg 71c Hippocastani seminis extractum siccum + Troxerutinum pharmaceutical forms for topical application (118 mg + 20 mg) / g 40 g - each item80 is added lp.80a, reading: 80a Lecithinum soiae oral fluid 9 g / 100 g 1 000 ml - item no.90 is replaced by the following: 90 Mentholum, Menthyli valeras solid forms for oral use or oral administration 60 mg 0.6 g - lp.102 is replaced by the following: 102 Octenidini dihydrochloridum + 2-Propanolum + 1-Propanolum pharmaceutical forms for application to the skin or mucous membranes (0.1 g + 45 g + 30 g) / 100 g 250 ml - item no.111, the following is added:111a is added: 111a Raphani sativi nigri radicis extractum siccum cum carbo activatus + Cynarae herbae extractum spissum + Acidum dehydrocholicum + Menthae piperitae aetheroleum solid oral forms 150 mg + 47 mg + 40 mg + 15 mg 4 500 mg + 1 410 mg + 1 200 mg + 450 mg - item no.116, the item is added.116a is added: 116a Silybi mariani extractum siccum + Pyridoxini hydrochloridum (Vitaminum B6) + Nicotinamidum + Thiamini hydrochloridum (Vitaminum B1) + Riboflavinum (Vitaminum B2) + Calcii pantothenas solid oral forms 241.3 mg + 10 mg + 10 mg + 10 mg + 4 mg + 4 mg 6 429 mg + 300 mg + 300 mg + 300 mg + 120 mg + 120 mg - po.122, the following is added:122a, reading: 122a Thymi herbae et Primulae radix extractum spissum + Thymolum syrup 218.0 mg + 0.989 mg / 5 ml 8 720.0 mg + 39.56 mg - no.132 is replaced by the following: 132 The complex of flavones isolated from the root of Scutellaria baicalensis + Allantoinum pharmaceutical forms for application to the skin (1.33 g + 1.00 g) / 100 g 35 g 3) in Annex 3 to the Regulation: a) in Table No. 1 "List of substances that may be present in medicinal products admitted to trading in generally accessible stores and specialist medical supply stores": - item no.17 is replaced by the following: 17 Carbo medicinalis (Carbo activatus) - after no.28, the following is added:28a is added as follows: 28a Diphenhydramini hydrochloridum - no.50 is replaced by the following: 50 Propanolum b) in Table 2 "Requirements for the composition, pharmaceutical form, strength and content of active substances in the packaging of a medicinal product or the packaging size of a medicinal product for medicinal products that may be marketed in generally accessible stores and shops specialized medical supplies ": - item no.13-15 are replaced by the following: 13 Aluminii hydroxidum solid oral or oral forms 500 mg 15,000 mg 14 Aluminii hydroxidum + Magnesii hydroxidum solid oral or oral forms 500 mg + 400 mg 15,000 mg + 12 000 mg 15 Aluminii hydroxidum + Magnesii hydroxidum + Simeticonum solid forms for oral or oral administration 500 mg + 400 mg + 25 mg 15,000 mg + 12,000 mg + 750 mg - No.20 and 21 are replaced by the following: 20 Calcii carbonas + Magnesii carbonas solid oral or oral forms 700 mg + 100 mg 21,000 mg + 3,000 mg 21 Carbo medicinalis (Carbo activatus) solid oral forms 300 mg 6,000 mg - in item no.32 the following item is added.32a is added: 32a Diphenhydramini hydrochloridum + Lidocaini hydrochloridum monohydricum pharmaceutical forms for application to the skin or mucous membranes (20 mg + 10 mg) / g 30 g - item no.38 is replaced by the following: 38 Nicotinum solid form for oral or oral administration 2 mg 72 mg - lp.41 is replaced by the following: 41 Octenidini dihydrochloridum + 2-Propanolum + 1-Propanolum pharmaceutical forms for application to the skin or mucous membranes (0.1 g + 45 g + 30 g) / 100 g 250 ml1) in Annex 1 to the Regulation:"2) the list of medicinal products authorized in pharmacy outlets shall include medicinal products containing the following active substances:- in point 6, the full stop is replaced by a semicolon and the following point 7 is added:"7) the list of medicinal products authorized in pharmacy outlets shall include medicinal products containing a standardized suspension of Escherichia coli bacterial culture.",b) in Table 1 "List of active substances that may exist in the form of various salts and isomers, esters, ethers or their salts (salts of isomers, esters and ethers), which are included, alone or in combination, in the medicinal products authorized in points pharmacy ":- in No.237, the following is added:237a is added as follows:- in No.344 is added 1p.344a as follows:- in No.634 is added 1p.634a is added:c) in Table 3 "Plant starting materials for the production of herbal active substances included in medicinal products authorized in pharmacy outlets. Herbal active substances may be in the form of herbal preparations or in their combinations":- in No.4, the following item is added.4a is added as follows:- in No.6, the following item is added.6a is added as follows:Angelicae archangelicae radix (Archangelicae radix)- in No.41, the following is added:41a is added:- in No.42, the following item is added.42a is added:Crataegi folium cum flore (Crataegi inflorescentiae)- in No.57 the following item is added.57a is added:- in No.89, the following item is added.89a and 89b as follows:- in No.164 is added lp.164a is added:- in No.165, the following is added:165a is added:Violae herba cum flore (Violae tricoloris herba)2) in Annex 2 to the Regulation:a) in the title of the Annex, the word "skepach" shall be replaced by the word "shops",b) in sec.1 in point 1 in lit.and the following thirty-eighth indent is added after the thirty-seventh indent:"- antiparasitic agents (P03A),",c) in Table 1 "Plant starting materials for the production of herbal active substances included in medicinal products admitted to trading in herbal and medical stores. Herbal active substances may be in the form of herbal preparations or in their combinations":- in No.4, the following item is added.4a is added as follows:- in No.6, the following item is added.6a is added as follows:Angelicae archangelicae radix (Archangelicae radix)- in No.41, the following is added:41a is added:- in No.42, the following item is added.42a is added:Crataegi folium cum flore (Crataegi inflorescentiae)- in No.57 the following item is added.57a is added:- in No.89, the following item is added.89a is added:- in No.164 is added lp.164a is added:- in No.165, the following is added:165a is added:Violae herba cum flore (Violae tricoloris herba)d) in Table 2 "List of substances authorized for marketing in herbal and medical stores, which may be combined with one or more plant material, or with their products, as long as they meet the requirements of Table 3":e) in Table 3 "Requirements for the composition, pharmaceutical form, strength and content of active substances in the packaging of a medicinal product or the packaging size of a medicinal product for medicinal products that may be marketed in herbal and medical stores":solid forms for oral administration6,000 mg + 3,600 mg- in No.20 is added lp.20a and 20b as follows:Aloe arborescentis recentis extractum fluidum + Acidum ascorbicum1,920 mg + 51 mg / 5 mlsolid forms for oral administration3.60-4.40 mg of hydroxyanthracene derivatives in terms of barbaloin + 1.0 mgAluminii hydroxidum cum Magnesii carbonate gelatum desiccatum + Magnesii hydroxidumsolid forms for oral or oral administration10,800 mg + 7,200 mg- in No.31, the following is added:31a and 31b as follows:Benzocainum + Extractum compositum spissum ex: Arnica herba, Thymi herba, Salviae folium, Calami rhizoma, Matricariae flos, Menthae piperitae herba, Quercus cortexmouthwash2 g + 50 g / 100 gBenzocainum + Matricariae extractum spissum, Belladonnae radicis extractum spissum, Extractum compositum spissum ex: Cytisi scoparii herba, Hippocastani cortice, Tormentillae rhizoma, Millefolii herba100 mg + 50 mg + 11.12-20 mg + 80 mg1,200 mg + 600 mg + 134.4-240 mg + 960 mgsolid forms for oral or oral administration67,200 mg + 9,600 mgCalcium (Calcii carbonas, Calcii glubionas, Calcii gluconas, Calcii lactobionas, Calcii lactogluconas, Calcii oxidum, Calcii phosphas)solid forms for oral or oral administrationsolid forms for oral administration- in No.51, the following is added:51a and 51b as follows:Convallariae extractum fluidum + Crataegi foil cum flore extractum fluidum + Troxerutinumliquid forms for oral administration(0.47 g + 0.4 g, 4.7 mg) / 1 mlCrataegi cum Valerianae tinctura + Convallariae tinctura titrata + Colae seminis extractum fluidum + Coffeinumliquid forms for oral administration(360 mg + 250 mg + 130 mg + 0.655 mg) / 1 mlsemi-solid pharmaceutical forms for application to the skin or mucous membranesliquid pharmaceutical forms for application to the skin or mucous membranes- in No.67, the following is added:67a is added:Extractum spissum compositum (4-6: 1) + Chamomillae extractum + Natrii citras + Kalii citras + Vitis idaeae folium extractum + Phaseoli pericarpiumsolid forms for oral administration86.2 mg + 78 mg + 19 mg + 16 mg + 16 mg + 8 mg5 172 mg + 4 680 mg + 1 140 mg + 960 mg + 480 mg- in No.71, the following is added:71a-71c as follows:Hippocastani seminis extractum siccum + Rutosidum trihydricum + Aesculinumsolid forms for oral administration25 mg + 15 mg + 0.5 mg750 mg + 450 mg + 15 mgHippocastani seminis extractum siccum + Rutosidum trihydricumsolid forms for oral administration3,000 mg + 1,800 mgHippocastani seminis extractum siccum + Troxerutinumpharmaceutical forms for application to the skin(118 mg + 20 mg) / g- in No.80 is added lp.80a is added:solid forms for oral or oral administrationpharmaceutical forms for application to the skin or mucous membranes(0.1 g + 45 g + 30 g) / 100 g- in No.111, the following is added:111a is added:Raphani sativi nigri radicis extractum siccum cum carbo activatus + Cynarae herbae extractum spissum + Acidum dehydrocholicum + Menthae piperitae aetheroleumsolid forms for oral administration150 mg + 47 mg + 40 mg + 15 mg4,500 mg + 1,410 mg + 1,200 mg + 450 mg- in No.116, the item is added.116a is added as follows:Silybi mariani extractum siccum + Pyridoxini hydrochloridum (Vitaminum B6) + Nicotinamidum + Thiamini hydrochloridum (Vitaminum B1) + Riboflavinum (Vitaminum B2) + Calcii pantothenassolid forms for oral administration241.3 mg + 10 mg + 10 mg + 10 mg + 4 mg + 4 mg6,429 mg + 300 mg + 300 mg + 300 mg + 120 mg + 120 mg- in No.122, the following is added:122a is added as follows:Thymi herbae et Primulae radix extractum spissum + Thymolum218.0 mg + 0.989 mg / 5 ml8 720.0 mg + 39.56 mgComplex of flavones isolated from the root of Scutellaria baicalensis + Allantoinumpharmaceutical forms for application to the skin(1.33 g + 1.00 g) / 100 g3) in Annex 3 to the Regulation:a) in Table 1 "List of substances that may be present in medicinal products authorized for marketing in generally accessible stores and specialist medical supply stores":- in No.28, the following is added:28a is added as follows:b) in Table 2 "Requirements for the composition, pharmaceutical form, strength and content of active substances in the packaging of a medicinal product or the packaging size of a medicinal product for medicinal products that may be marketed in generally accessible stores and specialist medical supply stores":solid forms for oral or oral administrationsolid forms for oral or oral administration15,000 mg + 12,000 mgAluminii hydroxidum + Magnesii hydroxidum + Simeticonumsolid forms for oral or oral administration500 mg + 400 mg + 25 mg12,000 mg + 750 mgsolid forms for oral or oral administration21,000 mg + 3,000 mgsolid forms for oral administration- in No.32, the following is added:32a is added as follows:Diphenhydramini hydrochloridum + Lidocaini hydrochloridum monohydricumpharmaceuticals for application to the skin or mucous membranes(20 mg + 10 mg) / gsolid forms for oral or oral administrationpharmaceutical forms for application to the skin or mucous membranes(0.1 g + 45 g + 30 g) / 100 g§ 2. The Regulation shall enter into force on the day following its publication.Minister of Health: wz.W. Kraska1) The Minister of Health manages the government administration department - health, pursuant to § 1 sec.2 of the Regulation of the Prime Minister of 27 August 2020 on the detailed scope of activities of the Minister of Health (Journal of Laws of 2021, item 932).